What management actually guided, with the source linked.
Signal compares the guide against the ClinicalTrials.gov-based estimate
and against last week's guide. 88 slipped or overdue vs guide. 96 already reported ✓.
| Ticker | Drug / Trial | Management says |
Source | CT.gov estimate | Signal |
|---|
| NBP | Givastomig Registrational Phase 3 study in 1L HER2-negative CLDN18.2-positive GEA | As early as YE 2026 “As early as YE 2026: Initiate Phase 3 registrational study under a potential Accelerated Approval Pathway” | PR · Aug 20, 2026 | — | Overdue |
| SANA | SC451 SC451 IND filing and Phase 1/2 start | as early as 2026 “Sana expects to file an IND and begin a Phase 1/2 clinical trial for SC451 as early as this year.” | PR · Aug 10, 2026 | — | Overdue |
| SANA | SG293 SG293 first-in-human data in non-Hodgkin lymphoma | as early as 2026 “Sana expects to generate first-in-human data for SG293 in non-Hodgkin lymphoma as early as this year.” | PR · Aug 10, 2026 | — | Overdue |
| MNPR | ALXN1840 (tiomolibdate choline) ALXN1840 rolling NDA in Wilson disease | Within the next few months (from August 2026) “The Company anticipates completing the NDA submission within the next few months.” | PR · Aug 12, 2026 | — | Overdue |
| AVXL | blarcamesine IND application for Fragile X syndrome | September 2026 “The IND for Fragile X syndrome is expected to be submitted in September, supported by the Orphan Drug Designation already granted by the FDA.” | PR · Aug 25, 2026 | — | Overdue |
| CRMD | REZZAYO sNDA for expanded indication of REZZAYO for prophylaxis of invasive fungal disease | Q3 2026 (sNDA submission); H1 2027 (potential FDA action if accepted) “the company anticipates FDA submission of the sNDA for an expanded indication of REZZAYO for the prophylaxis of invasive fungal disease in the third quarter of this year. Provided ” | PR · Aug 13, 2026 | — | Overdue |
| LEXX | DehydraTECH Human Study #7 / Animal Studies #1-2 in GLP-1 | Q3/Q4 2026 “Each of the studies mentioned above are in process and are fully funded with existing corporate resources. Results are expected during Q3 and Q4 of this calendar year.” | PR · Apr 29, 2026 | — | Overdue |
| NVS | ianalumab (VAY736) Sjogren's disease FDA approval | Q3 2026 “We've had the mid-cycle review meetings, so we're continuing to provide FDA all the information they're requesting. All on track from that point for a Q3 approval.” | Call · Jul 21, 2026 | — | — |
| RGNX | RGX-121 RGX-121 BLA resubmission | Q3 2026 “We are working to resubmit the BLA in Q3.” | Call · Aug 6, 2026 | — | — |
| RGNX | RGX-202 RGX-202 BLA submission under accelerated approval pathway | Q3 2026 “The Company is on track to initiate a BLA submission in Q3 2026 under the accelerated approval pathway, supporting potential approval in 2H 2027.” | Filing · Aug 6, 2026 | — | — |
| SCYX | SCY-247 (IV formulation) Phase 1 study of IV formulation | Q3 2026 “Dosing has been completed in the Phase 1 study of the IV formulation of SCY-247 and topline data are expected in the third quarter of 2026.” | PR · Aug 10, 2026 | — | — |
| SANA | UP421 UP421 investigator-sponsored trial in type 1 diabetes (EASD presentation 2026-10-02) | October 2, 2026 “14-month data from the study were presented at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting in July 2026, and additional data from the IST will be p” | PR · Aug 10, 2026 | — | Overdue |
| EVAX | EVX-01 Phase 2 in melanoma | October 24, 2026 “Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, will present three-year clinical eff” | PR · Jul 17, 2026 | — | Overdue |
| EIKN | EIK1001 TeLuRide-005 Phase 2 in NSCLC · NCT06246110 | October 26, 2026 “Eikon will present comprehensive updated data from TeLuRide-005 (NCT06246110), an ongoing open-label Phase 2 trial evaluating the safety and tolerability of EIK1001 in combination ” | PR · Aug 13, 2026 | — | — |
| GSK | bepirovirsen FDA regulatory decision (chronic hepatitis B) | 26 October 2026 “Regulatory review is ongoing in the US with a decision expected from the FDA by 26 October 2026.” | PR · Jul 28, 2026 | — | — |
| IONS | bepirovirsen BLA in chronic hepatitis B | October 26, 2026 (PDUFA) “The FDA has granted bepirovirsen Breakthrough Therapy designation and set a Prescription Drug User Fee Act (PDUFA) target action date of October 26, 2026.” | PR · Apr 28, 2026 | — | — |
| INO | INO-3107 BLA in recurrent respiratory papillomatosis | October 30, 2026 (PDUFA) “Instead, the FDA granted a standard 10-month review with a PDUFA target date set for October 30, 2026.” | PR · Mar 12, 2026 | — | Overdue |
| BHVN | BHV-1530 New Phase 1 data at ESMO Congress 2026 | October 2026 “New clinical data with BHV-1530, an FGFR3-directed ADC using a novel TopoIx payload, being presented at ESMO in October 2026” | PR · Aug 10, 2026 | — | — |
| CLNN | CNM-Au8 NDA submission for ALS (accelerated approval) | early Q4 2026 “Clene expects to submit a New Drug Application for CNM-Au8 in ALS under the accelerated approval pathway in early fourth quarter of 2026” | PR · Aug 14, 2026 | — | Overdue |
| IMTX | IMA203CD8 Phase 1 in PRAME-positive solid tumors | ESMO Congress 2026 “updated data across multiple PRAME-positive solid tumors are planned for presentation at the ESMO Congress 2026” | PR · Aug 18, 2026 | — | — |
| IOVA | lifileucel (SARATOGA UPS/DDLPS) Phase 1 SARATOGA in UPS and DDLPS | October 23-27, 2026 (ESMO) “Results will be highlighted in an oral presentation (abstract #3725RO) at the European Society for Medical Oncology (ESMO) meeting in Madrid, Spain, from October 23–27, 2026.” | PR · Aug 6, 2026 | — | — |
| ORIC | enozertinib (ORIC-114) 1L EGFR atypical monotherapy data at ESMO 2026 | October 2026 “October 2026: 1L EGFR atypical monotherapy data to be presented at ESMO Congress 2026” | PR · Aug 3, 2026 | Now - Nov 24, 2026 | Overdue |
| PCVX | VAX-31 adult Phase 3 OPUS-1 topline safety, tolerability and immunogenicity | by end of October 2026 “The Company also announced that topline safety, tolerability and immunogenicity data from the VAX-31 adult Phase 3 OPUS-1 trial are now expected by the end of October, narrowing it” | PR · Sep 3, 2026 | — | — |
| TNGX | vopimetostat Phase 1/2 combination with RAS(ON) inhibitors, ESMO data presentation | October 2026 (ESMO Congress, October 23-27) “We plan to share data from the Phase 1/2 trial of the combination of vopimetostat plus RAS(ON) inhibitors at the 2026 European Society for Medical Oncology (ESMO) Congress in Madri” | PR · Aug 11, 2026 | — | Overdue |
| VSTM | VS-7375 VS-7375: updated clinical data | October 2026 “Report updated VS-7375 clinical data in October 2026.” | PR · Aug 6, 2026 | — | — |
| ZLAB | zoci Phase 1 trial of zoci in combination with atezolizumab with or without chemotherapy (first-line SCLC): initial data at ESMO 2026 | October 2026 “Report initial Phase 1 data evaluating zoci in combination with atezolizumab, with or without chemotherapy, at the European Society for Medical Oncology (ESMO) 2026 Congress in Oct” | PR · Aug 6, 2026 | — | Overdue |
| ZNTL | azenosertib DENALI Part 1b overall survival analysis of azenosertib in platinum-resistant ovarian cancer: rapid oral presentation at ESMO 2026 · NCT05128825 | October 2026 “Azenosertib in platinum-resistant ovarian cancer (PROC): overall survival analysis from Part 1b of the DENALI study (GOG-3066) – rapid oral presentation, Friday, October 23, 2026, ” | PR · Jul 17, 2026 | — | — |
| AGIO | mitapivat sNDA for sickle cell disease, PDUFA goal date | November 1, 2026 “The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA's accelerated approval pathway, is November 1, 2026.” | PR · Jul 7, 2026 | — | — |
| CGEM | velinotamig Phase 1 dose escalation study in SLE (multi-dose regimen data, ACR Convergence 2026) | November 8, 2026 “Multi-dose regimen data from the ongoing Genrix Bio Phase 1 dose escalation study in SLE to be shared in poster session at ACR Convergence 2026 on November 8, 2026, 10:30 a.m. to 1” | PR · Sep 24, 2026 | — | — |
| NKTX | NKX019 Phase 1/2 Ntrust-2 initial data in idiopathic inflammatory myopathy (myositis) at ACR Convergence 2026 (oral presentation) · NCT06733935 | November 8, 2026 “Presentations include an oral presentation in myositis on November 8, a poster in systemic sclerosis on November 9, and an oral presentation of safety data across autoimmune indica” | PR · Nov 5, 2026 | — | — |
| NKTX | NKX019 Phase 1/2 Ntrust-2 initial data in systemic sclerosis (scleroderma) at ACR Convergence 2026 (poster presentation) · NCT06733935 | November 9, 2026 “Presentations include an oral presentation in myositis on November 8, a poster in systemic sclerosis on November 9, and an oral presentation of safety data across autoimmune indica” | PR · Nov 5, 2026 | — | Slipped |
| NRXP | preservative-free ketamine Preservative-free ketamine ANDA GDUFA goal date | November 10, 2026 “The acknowledgement letter revised the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will not require a substantial expenditure of FDA resources.” | PR · Sep 15, 2026 | — | — |
| NKTX | NKX019 Phase 1/2 Ntrust-1 and Ntrust-2 safety data in autoimmune indications at ACR Convergence 2026 (oral presentation) · NCT06557265 | November 11, 2026 “Presentations include an oral presentation in myositis on November 8, a poster in systemic sclerosis on November 9, and an oral presentation of safety data across autoimmune indica” | PR · Nov 5, 2026 | — | Slipped |
| CYTK | aficamten MAPLE-HCM sNDA (oHCM monotherapy); ACACIA-HCM nHCM sNDA | November 14, 2026 (MAPLE-HCM sNDA PDUFA date); Q4 2026 (nHCM sNDA filing) “Supplemental NDA for MAPLE-HCM Accepted for Filing by FDA with PDUFA Date of November 14, 2026. We expect to file a Supplemental NDA for nHCM in Q4 2026.” | PR · Aug 6, 2026 | — | — |
| SMMT | ivonescimab (HARMONi BLA) HARMONi Phase 3 in EGFR-mutant NSCLC after third-generation EGFR TKI (FDA BLA under review) · NCT06396065 | November 14, 2026 “The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.” | PR · Jul 23, 2026 | — | — |
| IPHA | IPH4502 Phase 1 dose escalation | November 18, 2026 (ENA) “Initial Phase 1 dose-escalation data will be presented at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026) on November 18, 2026.” | PR · Sep 16, 2026 | — | — |
| APRE | APR-1051 ACESOT-1051 Phase 1 oral presentation at EORTC-NCI-AACR · NCT06260514 | 2026-11-20 “We look forward to presenting an update from our ongoing Phase 1 ACESOT-1051 trial at the EORTC-NCI-AACR Symposium and sharing these data with the international oncology community.” | PR · Sep 22, 2026 | — | — |
| CAPR | deramiocel BLA for Duchenne muscular dystrophy (PDUFA target action date) | November 22, 2026 “the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for its Biologics License Application (BLA) for Deramiocel, a” | PR · Aug 24, 2026 | — | — |
| SVRA | molgramostim (MOLBREEVI, US BLA) autoimmune pulmonary alveolar proteinosis (aPAP), FDA BLA under review | November 22, 2026 “MOLBREEVI BLA PDUFA Target Action Date Set for November 22, 2026” | PR · Aug 12, 2026 | — | — |
| SNY | venglustat LEAP2MONO Phase 3 in type 3 Gaucher disease (FDA NDA under priority review) · NCT05222906 | November 25, 2026 “The target action date for the FDA decision is November 25, 2026.” | PR · May 28, 2026 | — | — |
| BBIO | BBP-418 NDA PDUFA for limb-girdle muscular dystrophy | November 27, 2026 “PDUFA date set for November 27, 2026 with Priority Review” | PR · Aug 10, 2026 | — | — |
| ANL | AN4005 Expansion cohorts clinical update | 2026 (SITC meeting) “A clinical update from the ongoing expansion cohorts is expected to be presented at the 2026 Society for Immunotherapy of Cancer (SITC) meeting.” | PR · Aug 14, 2026 | — | — |
| ANNX | ANX1502 Proof-of-concept trial in cold agglutinin disease | Fall 2026 “Next Milestone: Update on POC trial in CAD anticipated in the Fall of 2026.” | PR · Aug 12, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| BOLT | BDC-4182 Initial Phase 1/2 data in gastric/gastroesophageal cancer · NCT06921837 | Nov 2026 “We expect to report initial clinical data from BDC-4182 with our third quarter 2026 results.” | PR · Aug 11, 2026 | — | — |
| COGT | bezuclastinib Potential FDA approval in GIST (PDUFA) | November 30, 2026 “Potential FDA approval of bezuclastinib in GIST - PDUFA date of November 30, 2026” | PR · Aug 10, 2026 | — | — |
| DWTX | Halneuron HAL-CINP Phase 2b in chemotherapy-induced neuropathic pain · NCT06848348 | November 2026 “The Company anticipates topline data readout of the study in November 2026.” | PR · Sep 14, 2026 | — | — |
| MLTX | Sonelokimab Sonelokimab HS BLA acceptance and Priority Review decision | End of November 2026 “acceptance, including a decision on Priority Review designation associated with the inclusion of VELA-TEEN adolescent data, is expected by end of November 2026” | PR · May 10, 2026 | — | Slipped |
| PEPG | PGN-EDODM1 FREEDOM2 Phase 2 MAD cohort data, 10 mg/kg | November 2026 “Data from this cohort is on track to be reported in November.” | PR · Aug 6, 2026 | — | — |
| REGN | cemdisiran cemdisiran NDA under FDA priority review | November 2026 “The FDA will review the New Drug Application (NDA) under priority review with a target action date in November 2026, following use of a Priority Review Voucher.” | PR · Jul 30, 2026 | — | — |
| SLGL | SGT-610 (patidegib gel 2%) Phase 3 (SGT-610-01) in Gorlin syndrome | late November 2026 “Sol-Gel expects to report top-line results in late November 2026.” | PR · Sep 17, 2026 | Nov 12 - Dec 24 | On track |
| VRTX | povetacicept BLA for povetacicept in IgA nephropathy: PDUFA target action date | 2026-11-30 “The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2026.” | PR · Jun 1, 2026 | — | — |
| ANAB | Quimilza (imsidolimab) Generalized pustular psoriasis (GPP) PDUFA | 2026-12-12 “FDA target action date (PDUFA) of Dec. 12, 2026, for Quimilza in generalized pustular psoriasis (GPP)” | PR · Sep 21, 2026 | — | — |
| VNDA | Quimilza (imsidolimab) BLA for Quimilza (imsidolimab) in generalized pustular psoriasis (GPP): PDUFA target action date | 2026-12-12 “Quimilza™ (imsidolimab) BLA for GPP under review by the FDA; PDUFA target action date of December 12, 2026” | PR · Aug 5, 2026 | — | — |
| MLYS | Lorundrostat Lorundrostat NDA (PDUFA) | December 22, 2026 (PDUFA target action date) “PDUFA target date of December 22, 2026 for lorundrostat; commercial preparations on-track for launch upon approval.” | PR · Aug 11, 2026 | — | — |
| GILD | anito-cel iMMagine-1 in 4L+ R/R multiple myeloma | by 23 December 2026 “4L R/R Multiple Myeloma FDA Decision Expected by 23 December 2026” | Deck · Aug 4, 2026 | — | — |
| PRAX | relutrigine (PRAX-562) NDA for relutrigine, PDUFA date | December 27, 2026 “PDUFA date of December 27, 2026.” | PR · Aug 6, 2026 | — | — |
| COGT | bezuclastinib Potential FDA approval in NonAdvSM (PDUFA) | December 30, 2026 “Potential FDA approval of bezuclastinib in NonAdvSM - PDUFA date of December 30, 2026” | PR · Aug 10, 2026 | — | Slipped |
| ABCL | ABCL575 Phase 1 study · NCT07108894 | Q4 2026 “Completed dosing for the Phase 1 study of ABCL575, with top-line data readout expected in Q4 2026.” | PR · Aug 5, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ABSI | ABS-201 HEADLINE Phase 1/2a in pattern hair loss, interim proof-of-concept · NCT07317544 | H2 2026 “Absci anticipates reporting interim proof-of-concept data in the second half of 2026 and full proof-of-concept data in early 2027.” | Filing · Aug 11, 2026 | Est. Nov 7, 2026 half midpoint | — |
| ABVX | obefazimod NDA submission to FDA in ulcerative colitis | late Q4 2026 “Abivax intends to submit an NDA to the FDA in late fourth quarter 2026.” | PR · Jun 1, 2026 | — | — |
| ACHV | cytisinicline NDA resubmission for smoking cessation | Q4 2026 “Achieve intends to resubmit its NDA in the fourth quarter of 2026, naming Adare as its primary manufacturing partner, with potential FDA approval in the first half of 2027, followe” | PR · Jun 22, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ACIU | ACI-19764 Phase 1 trial in healthy volunteers, results · NCT07463196 | H2 2026 “Results from Phase 1 trial in healthy volunteers H2 2026” | PR · Aug 5, 2026 | Jan 12 - Feb 23 | Guide earlier than CT.gov |
| ACIU | ACI-19764 Phase 1b patient cohort, results · NCT07463196 | H2 2026 “Results from Phase 1b in patient cohort H2 2026” | PR · Aug 5, 2026 | Jan 12 - Feb 23 | Guide earlier than CT.gov |
| ACRS | ATI-9494 IND filing | Q4 2026 “On Track for Expected Fourth Quarter 2026 Filing of Investigational New Drug (IND) Application for ATI-9494, Aclaris' Investigational Dual Inhibitor of ITK and TXK” | Filing · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ACRS | bosakitug (ATI-045) Phase 2 in atopic dermatitis, topline · NCT07011706 | Q4 2026 “On Track for Expected Fourth Quarter 2026 Readout of Top Line Results from Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug: Enrollment is complete in this ” | Filing · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ACRV | ACR-368 Phase 2b in serous endometrial cancer, prespecified interim analysis and data update · NCT05548296 | H2 2026 “A prespecified simultaneous interim analysis and data update from both all-comer (biopsy-independent) serous EC arms of the ACR-368 Phase 2b study in second half of 2026” | PR · Aug 12, 2026 | Est. Nov 7, 2026 half midpoint | — |
| ADCT | ZYNLONTA (loncastuximab tesirine-lpyl) LOTIS-7 Phase 1b ZYNLONTA + glofitamab in r/r DLBCL, Breakthrough Therapy designation submission | 2026 “The Company is also evaluating a regulatory pathway for this combination and plans to submit for Breakthrough Therapy designation (BTD) this year.” | PR · Aug 13, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| ADCT | ZYNLONTA (loncastuximab tesirine-lpyl) investigator-initiated Phase 2 monotherapy in marginal zone lymphoma, updated data presentation; BTD submission planned | before end of 2026 “Updated MZL data were submitted to ASH and the Company anticipates presentation of this data before the end of the year, with publication and compendia submission to follow. The Co” | PR · Aug 13, 2026 | — | — |
| ALKS | alixorexton (ALKS 2680) Vibrance-3 Phase 2 in idiopathic hypersomnia | 2H 2026 “We are excited to continue advancing enrollment in the phase 3 Brilliance Studies and work toward completing the Vibrance-3 phase 2 study in IH later this year.” | PR · Jul 13, 2026 | Est. Nov 7, 2026 half midpoint | — |
| ALLO | ALLO-329 RESOLUTION Phase 1, clinical and translational update | Q4 2026 “The Company remains on track to provide a clinical and translational update in the fourth quarter of 2026.” | PR · Aug 12, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ALMS | envudeucitinib NDA submission in moderate-to-severe plaque psoriasis | 4Q 2026 “Alumis remains on track to submit an NDA for envudeucitinib in moderate-to-severe plaque psoriasis in 4Q 2026” | Filing · Sep 1, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ALNY | ALN-2232 Phase 1 in obesity and weight management, results | H2 2026 “In the second half of 2026, Alnylam expects to announce clinical data from additional pipeline programs, including: Results from a Phase 1 clinical trial of ALN-2232 in obesity and” | PR · Jul 30, 2026 | Est. Nov 7, 2026 half midpoint | — |
| ALNY | ALN-6400 Phase 1 and Phase 2 in healthy volunteers and HHT patients, results · NCT06659640 | H2 2026 “In the second half of 2026, Alnylam expects to announce clinical data from additional pipeline programs, including: Results from Phase 1 and Phase 2 clinical trials of ALN-6400 in ” | PR · Jul 30, 2026 | Est. Nov 7, 2026 half midpoint | — |
| ALVO | AVT05 U.S. regulatory approval | Q4 2026 “In the U.S., we are expecting regulatory approval in the fourth quarter of this year” | Call · Aug 20, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ALXO | ALX2004 Phase 1 in EGFR-expressing solid tumors | 2H 2026 “Strong enrollment momentum in Phase 1 clinical trial of ALX2004 in EGFR expressing solid tumors with initial safety data on-track for 2H 2026” | PR · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | — |
| ALZN | AL001 Phase II “Lithium in Brain” study in bipolar disorder | Q4 2026 “In March 2026, we announced the initiation of the Phase II Clinical Trial of AL001 ‘Lithium in Brain’ Study in Patients with BD and expect to report topline data in the fourth quar” | Filing · Jul 22, 2026 | Jan 12 - Feb 23 | Guide earlier than CT.gov |
| AMGN | dazodalibep OASIZ 303 Phase 3 in moderate-to-severe symptomatic Sjögren’s disease | Q4 2026 “The Phase 3 OASIZ 303 study of dazodalibep in moderate-to-severe symptomatic Sjögren’s disease is expected to complete in Q4 2026.” | PR · Sep 22, 2026 | Dec 3, 2026 - Jan 14, 2027 | On track |
| AMLX | avexitide NDA submission for post-bariatric hypoglycemia | end of 2026 “Amylyx plans to submit a New Drug Application (NDA) to the FDA by the end of 2026.” | PR · Aug 18, 2026 | — | — |
| ANIP | ILUVIEN SYNCHRONICITY Phase 4 in NIU-PS | Q4 2026 “The Company announced 6-month topline data from the Phase 4 open-label single-arm SYNCHRONICITY clinical trial in chronic non-infectious uveitis affecting the posterior segment of ” | PR · Aug 7, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ANNX | tanruprubart FORWARD in Guillain-Barre syndrome, BLA submission | Q4 2026 “Next Milestone: Biologics License Application (BLA) submission with U.S./European data from FORWARD trial expected in fourth quarter of 2026.” | PR · Aug 12, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ANNX | vonaprument ARCHER II Phase 3 in geographic atrophy, Month 15 primary analysis | Q4 2026 “Topline results from the Month 15 primary analysis are expected in the fourth quarter of 2026.” | PR · Aug 12, 2026 | Dec 12, 2026 - Jan 23, 2027 | Pulled forward |
| ARGX | empasiprubart EMPASSION registrational in multifocal motor neuropathy | Q4 2026 “Topline results from registrational EMPASSION study (MMN) expected in fourth quarter of 2026” | PR · Jul 23, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ARQT | ZORYVE foam 0.3% Phase 2 in vitiligo, topline and program decision | Q4 2026 “Completed enrollment of the Phase 2 trial of ZORYVE foam 0.3% in individuals with vitiligo with disclosure of topline results and decision on program advancement anticipated in Q4 ” | PR · Aug 5, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ARVN | ARV-393 Phase 1 dose escalation in relapsed/refractory NHL · NCT06393738 | 2H 2026 “Share data from early monotherapy cohorts in the ongoing Phase 1 dose escalation clinical trial in patients with relapsed/refractory NHL(ClinicalTrials.gov Identifier: NCT06393738)” | PR · Aug 4, 2026 | Est. Nov 7, 2026 half midpoint | — |
| ARVN | ARV-806 Phase 1 monotherapy dose escalation in KRAS G12D solid tumors · NCT07023731 | 2H 2026 “Reiterated plan to share initial data from the Phase 1 monotherapy dose escalation clinical trial in the second half of 2026.” | PR · Aug 4, 2026 | Jan 11 - Feb 22 | Guide earlier than CT.gov |
| ARWR | plozasiran sHTG sNDA (SHASTA-3, SHASTA-4, MUIR-3) | before end of 2026 “Arrowhead intends to leverage data from the Phase 3 SHASTA-3, SHASTA-4 and MUIR-3 studies to seek marketing authorization for plozasiran in the broader sHTG population in multiple ” | PR · Aug 30, 2026 | — | — |
| ASND | YUVIWEL (navepegritide) EU Marketing Authorisation Application in achondroplasia | Q4 2026 “In the EU, a Marketing Authorisation Application (“MAA”) is under review with a decision expected in the fourth quarter of 2026.” | Filing · Aug 13, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ATNM | Actimab-A Multitumor Phase 1 MDSC basket trial | 2H 2026 “2H:26 Multitumor Phase 1 data from MDSC basket trial” | Deck · 2026-04 | Est. Nov 7, 2026 half midpoint | — |
| ATNM | Iomab-ACT SCD and commercial CAR-T clinical trials | 2H 2026 “2H:26 Additional clinical data from Iomab-ACT SCD and commercial CAR-T trials” | Deck · 2026-04 | Est. Nov 7, 2026 half midpoint | — |
| ATTO | ATTO-1310 Phase 1b in chronic pruritus and high-itch AD | Q4 2026 “Complete Phase 1b data are expected in the fourth quarter of 2026.” | PR · Sep 2, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| AUTL | obe-cel CARLYSLE Phase 1 in severe refractory SLE | Q4 2026 “The next data update from the Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (SLE) has been submitted for presentation at the American Colle” | PR · Aug 11, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| AXSM | solriamfetol Phase 3 ENGAGE in binge-eating disorder | Q4 2026 “The Company anticipates topline results from the ENGAGE Phase 3 trial in the fourth quarter of 2026.” | PR · Aug 10, 2026 | Jan 12 - Feb 23 | Guide earlier than CT.gov |
| AZTR | ATR-04 first cohort of Phase 1/2 in EGFR inhibitor-associated rash · NCT06830863 | Q4 2026 “Topline data from first cohort of Phase 1/2 trial expected in Q4-2026.” | PR · Aug 12, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| BBIO | infigratinib ACCEL Phase 2 program update in hypochondroplasia | 2H 2026 “An update of the Phase 2 program in hypochondroplasia is expected in the second half of 2026.” | PR · Aug 10, 2026 | Est. Nov 7, 2026 half midpoint | — |
| BBOT | BBO-11818 and BBO-10203 Monotherapy data update | Q4 2026 “BBO-11818 and BBO-10203 monotherapy data update in the fourth quarter of 2026.” | PR · Sep 8, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| BCDA | CardiAMP cell therapy Shonin submission to Japan PMDA for ischemic heart failure | Q4 2026 “We are preparing the CardiAMP cell therapy PMDA submission for the fourth quarter” | Filing · Aug 12, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| BCRX | BCX17725 Part 4 data in Netherton syndrome | by end of 2026 “The company is dosing in Part 4 of this trial, which will enroll up to 12 patients for three months, and expects to report data from this part by the end of 2026.” | PR · Aug 5, 2026 | — | — |
| BDTX | silevertinib Phase 2 update in frontline non-classical EGFRm NSCLC and update on FDA feedback for pivotal path | Q4 2026 “The Company plans to provide an update on the Phase 2 trial of silevertinib in frontline patients with non-classical EGFR-mutant (EGFRm) NSCLC in the fourth quarter of 2026.” | PR · Aug 5, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| BEAM | BEAM-301 Initial clinical data | 2026 “Beam expects to report initial clinical data in 2026.” | PR · Aug 4, 2026 | Jan 12 - Feb 23 | Guide earlier than CT.gov |
| BEAM | risto-cel Updated BEACON trial data | by year-end 2026 “Beam expects to report updated data for the BEACON trial by year-end 2026 and submit a biologics license application (BLA) for risto-cel as early as year-end 2026.” | PR · Aug 4, 2026 | — | — |
| BEAM | risto-cel BLA submission | as early as year-end 2026 “Beam expects to report updated data for the BEACON trial by year-end 2026 and submit a biologics license application (BLA) for risto-cel as early as year-end 2026.” | PR · Aug 4, 2026 | — | — |
| BHVN | opakalim Phase 2/3 RISE3 topline in focal epilepsy | 2H 2026 “Topline results from the Phase 2/3 RISE3 trial in focal epilepsy remain on track for 2H 2026.” | PR · Aug 10, 2026 | Est. Nov 7, 2026 half midpoint | — |
| BHVN | taldefgrobep alfa Phase 2 obesity topline | 2H 2026 “Topline data expected during 2H 2026.” | PR · Aug 10, 2026 | Est. Nov 7, 2026 half midpoint | — |
| BIIB | litifilimab Registrational data in SLE | by end of 2026 “Registrational data for litifilimab in SLE expected by end of 2026 and additional Phase 3 readouts for litifilimab in CLE, felzartamab in AMR, and zorevunersen in Dravet syndrome a” | PR · Aug 4, 2026 | — | — |
| BIOA | BGE-102 Phase 2 QUELL-CV in obesity with elevated systemic inflammation and cardiovascular risk factors | 2H 2026 “We have dosed the first participant in QUELL-CV, our Phase 2 trial in patients with obesity and inflammation at elevated cardiovascular risk, with topline data anticipated in the s” | PR · Aug 5, 2026 | Jan 11 - Feb 22 | Guide earlier than CT.gov |
| BLRX | motixafortide Interim/futility analysis in CheMo4METPANC (PDAC) | 2026 “A prespecified interim/futility analysis is planned when 40% of progression-free survival (PFS) events are observed, which the Company continues to anticipate will occur in 2026.” | PR · Aug 31, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| BNTX | BNT113 Phase 3 PFS interim analysis in 1L HPV16+ PD-L1+ HNSCC | later in 2026 “For BNT113, based on current event accrual projections, we expect a phase III interim analysis for progression-free survival later this year.” | Call · Aug 4, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| BNTX | trastuzumab pamirtecan Phase 3 primary analysis in chemo-naive HR+ HER2-low breast cancer | Q4 2026 “With the primary analysis in breast cancer expected in the fourth quarter of 2026, we will determine the optimal regulatory pathway based on aggregated data across both indications” | Call · Aug 4, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| BSEM | BioRetain-Preserved Amnion (BRA) Final results of DFU randomized controlled trial | late 2026 “Final results are expected in late 2026, after which we will determine whether to continue further testing, given that BRA products represented less than 1% of product sales in 202” | Filing · Sep 4, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| BSEM | BioRetain-Processed Amnion Chorion (BR-AC) Final results of VLU randomized controlled trial | late 2026 “Final study results are expected in late 2026.” | Filing · Sep 4, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| CADL | aglatimagene besadenovec BLA submission in localized prostate cancer | Q4 2026 “This quarter reflects meaningful execution across the company as we advance aglatimagene toward a planned BLA submission in the fourth quarter of 2026 and continue to build the fou” | PR · Aug 13, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| CADL | linoserpaturev Phase 1b clinical trial arm C in recurrent high-grade glioma | Q4 2026 “The Company expects to present potential long-term survival data from arm C of its phase 1b clinical trial of linoserpaturev in patients with recurrent high-grade glioma (rHGG) in ” | PR · Aug 13, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| CGEM | CLN-049 Phase 1 dose escalation study in relapsed/refractory AML (updated data) | December 2026 “Updated data from the dose escalation portion of the Phase 1 study in December” | PR · Sep 24, 2026 | Dec 13, 2026 - Jan 24, 2027 | On track |
| CGEM | CLN-978 Multi-dose and single target dose regimen data in SLE, RA and Sjogren's disease | December 2026 “Multi-dose and single target dose regimen data in SLE, RA, and SjD in December” | PR · Sep 24, 2026 | — | — |
| CGON | cretostimogene BLA completion in HR BCG-unresponsive NMIBC | Q4 2026 “Completion of BLA submission in initial indication of HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease in 4Q'26” | PR · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| CHRS | casdozokitug randomized Phase 2 trial of casdozokitug/toripalimab/bevacizumab in 1L unresectable HCC · NCT06679985 | 2H 2026 “Enrollment is complete in the randomized Phase 2 trial of casdozokitug/toripalimab/bevacizumab in 1L uHCC and the first data readout is expected 2H 2026.” | PR · Aug 5, 2026 | Est. Nov 7, 2026 half midpoint | — |
| CLDI | CLD-401 IND filing (RedTail platform lead candidate) | Q4 2026 “I anticipate that we will complete our IND-enabling studies for CLD-401, the lead candidate from the RedTail platform, and submit an IND application by the end of this year.” | PR · Jan 28, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| CLLS | eti-cel NATHALI-01 Phase 1 (full dataset) · NCT05607420 | Q4 2026 “Cellectis expects to present the full Phase 1 dataset in Q4 2026.” | PR · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| CLLS | lasme-cel BALLI-01 pivotal Phase 2 trial (first interim analysis) · NCT04150497 | Q4 2026 “The first interim analysis for the pivotal Phase 2 of the BALLI-01 trial is expected in Q4 2026.” | PR · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| CLYM | CLYM116 Phase 1 study + Mabworks Phase 1 healthy volunteer study in China (medical meeting presentation) | Q4 2026 “Additional data from the ongoing Phase 1 study and initial reporting of Beijing Mabworks Biotech Co., Ltd. (Mabworks) Phase 1 healthy volunteer study in China to be presented at an” | PR · Sep 3, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| CMPS | COMP360 NDA final submission | Q4 2026 “A rolling New Drug Application (NDA) submission and initial review with the U.S. Food and Drug Administration (FDA) is underway and final submission remains on track to be complete” | PR · Jul 7, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| CMPX | CTX-10726 Phase 1 study (initial clinical data) | Q4 2026 “The first patients have been dosed in the Phase 1 study, and the study is actively enrolling, with initial clinical data expected in Q4 2026.” | PR · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| CMPX | CTX-8371 Phase 1 cohort expansions (additional data) | Q4 2026 “Additional data from the cohort expansions are expected in Q4 2026.” | PR · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| COGT | bezuclastinib SUMMIT extension trial ('avapritinib switch') preliminary results | end of 2026 “Announced completion of enrollment in the 'avapritinib switch' SUMMIT extension trial with preliminary results expected by end of 2026.” | PR · Aug 10, 2026 | — | Slipped |
| CRIS | Emavusertib TakeAim CLL Phase 2 of emavusertib in combination with zanubrutinib · NCT07271667 | December 2026 “Today, Curis is announcing that it has achieved the previously stated goal of dosing the first five patients in the TakeAim CLL study and reaffirmed its expectation to report initi” | PR · Jul 30, 2026 | — | — |
| CRSP | CTX611 Phase 2 clinical trial in patients undergoing total knee arthroplasty | 2H 2026 “The Company expects to provide an update in the second half of 2026.” | PR · Aug 3, 2026 | Est. Nov 7, 2026 half midpoint | — |
| CRSP | zugo-cel Phase 1 trials in autoimmune disease and Phase 1/2 trial in B-cell malignancies | 2H 2026 “The Company expects to provide further updates in the second half of 2026. In immuno-oncology, the Phase 1/2 clinical trial of zugo-cel in B-cell malignancies is ongoing, with upda” | PR · Aug 3, 2026 | Est. Nov 7, 2026 half midpoint | — |
| CRVO | neflamapimod Phase 2a RESTORE trial in patients recovering from acute ischemic stroke | 2H 2026 “CervoMed expects to report topline data from its Phase 2a RESTORE trial evaluating neflamapimod in patients recovering from acute ischemic stroke in the second half of 2026.” | PR · Aug 10, 2026 | Nov 11 - Dec 23 | Pulled forward |
| CTMX | Varseta-M (CX-2051) Phase 1 monotherapy trial in colorectal cancer | end of 2026 “A Phase 1 data update is expected by the end of 2026 with a focus on dose selection for late phase development.” | PR · Aug 6, 2026 | — | — |
| CURX | Phyto-N IND submission for ulcerative colitis | Q4 2026 “Curanex is advancing Phyto-N toward a planned Investigational New Drug ("IND") submission to the U.S. Food and Drug Administration ("FDA") for ulcerative colitis in the fourth quar” | PR · May 14, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| DMRA | DMR-002 first regulatory submission | 2H 2026 “DMR-002 (Fc enhanced, half-life extended anti-mutCALR monoclonal antibody): first regulatory submission expected in the second half of 2026” | PR · Aug 10, 2026 | Est. Nov 7, 2026 half midpoint | — |
| DNTH | claseprubart Phase 2 MoMeNtum in MMN | December 2026 “Top-line results with 46 patients are on track for December '26.” | PR · Aug 4, 2026 | — | — |
| DTIL | PBGENE-DMD Phase 1/2 FUNCTION-DMD in Duchenne muscular dystrophy | Q4 2026 “We are grateful to the patient, their family, and the clinical team for their commitment to advancing this important work, and we look forward to reporting initial safety data by y” | PR · Aug 24, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| EIKN | EIK1006 IND submission | end of 2026 “Eikon expects to submit an investigational new drug application (IND) for EIK1006 by the end of 2026.” | PR · Aug 13, 2026 | — | — |
| ELUT | NXT-41 | Q4 2026 “The Company continues to expect FDA clearance for NXT-41 in the fourth quarter of 2026 and for NXT-41x in the first half of 2027.” | PR · Aug 13, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ENGN | detalimogene LEGEND Cohort 1 | Q4 2026 “enGene expects to report updated data on key primary and secondary regulatory endpoints (CR at any time and Duration of Response (DOR) ≥ 12 months), as well as additional durabilit” | PR · Sep 8, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ENTA | EDP-978 Phase 1 in urticaria | Q4 2026 “Additionally, in immunology, we are focused on reporting topline data from our Phase 1 study of EDP-978 in the fourth quarter of 2026, while also advancing EPS-3903, our oral, once” | PR · Aug 10, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ENTA | EPS-3903 | 2H 2026 “On Track to File an IND for EPS-3903, an Oral, Once-Daily STAT6 Inhibitor and to Select an MRGPRX2 Development Candidate, in 2H 2026” | PR · Aug 10, 2026 | Est. Nov 7, 2026 half midpoint | — |
| EOLS | Evolysse Sculpt | Q4 2026 “The anticipated U.S. approval of Evolysse® Sculpt in the fourth quarter of 2026; however, guidance assumes no revenue contribution from the product.” | PR · Aug 5, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| EPRX | EP-104GI RESOLVE Phase 2b in eosinophilic esophagitis (interim) | Q4 2026 “including the Phase 2b Eosinophilic Esophagitis (EoE) trial with interim data expected to be released in Q4 highlighting key clinical and histologic endpoints” | PR · Aug 11, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| EQ | EQ504 Phase 1 proof-of-mechanism | approximately six months after Q4 2026 initiation “We expect to initiate this study in the fourth quarter of 2026 and report topline data approximately six months thereafter.” | PR · Aug 13, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ERAS | ERAS-4001 Phase 1 monotherapy | 2H 2026 “Preliminary safety, tolerability, PK, and initial efficacy Phase 1 monotherapy data expected in the second half of 2026” | Filing · Aug 11, 2026 | Est. Nov 7, 2026 half midpoint | — |
| ERNA | ERNA-101 | Q4 2026 “The Company is focused on advancing ERNA-101 toward a planned IND submission in the fourth quarter of 2026.” | PR · Sep 15, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ETON | AMGLIDIA | by the end of 2026 “The Company plans to initiate a bioavailability study for the product later this month and remains on track to submit an NDA by the end of 2026, allowing for potential approval and” | PR · Aug 13, 2026 | — | — |
| EXEL | zanzalintinib Phase 3 STELLAR-304 of zanzalintinib plus nivolumab in untreated advanced non-clear-cell RCC | 2H 2026 “In May 2026, Exelixis announced that the company expects topline results from the STELLAR-304 trial in the second half of 2026, depending on event rates.” | PR · Aug 4, 2026 | Est. Nov 7, 2026 half midpoint | — |
| FBIO | Triplex CMV in HIV/CMV co-infected patients | by the end of 2026 “Triplex is currently in multiple ongoing clinical trials for cytomegalovirus (CMV) treatment and prevention in solid organ and stem cell transplants, combination trials with CAR T ” | PR · Aug 13, 2026 | — | — |
| FBLG | CYWC628 Phase 1/2 in diabetic foot ulcer | by the end of 2026 “Anticipates completion and disclosure of primary safety and efficacy results by the end of 2026.” | PR · Jul 31, 2026 | — | — |
| FTH | PIK-201 PIKTOR Phase 2 in endometrial cancer | by year-end 2026 “We look forward to reading out topline data from our Phase 2 PIK-201 trial in endometrial cancer, which is expected by year-end.” | PR · Aug 4, 2026 | — | — |
| GILD | Livdelzi IDEAL in 2L primary biliary cholangitis | 2H 2026 “Livdelzi, IDEAL, 2L Primary Biliary Cholangitis, Phase 3 Update” | Deck · Aug 4, 2026 | Est. Nov 7, 2026 half midpoint | — |
| GILD | Trodelvy ASCENT-03 in 1L mTNBC (PD-L1-) | 2H 2026 “ASCENT-03, (PD-L1-) 1L mTNBC, FDA Decision” | Deck · Aug 4, 2026 | Est. Nov 7, 2026 half midpoint | — |
| GILD | Trodelvy ASCENT-04 in 1L mTNBC (PD-L1+) | 2H 2026 “ASCENT-04, 1L mTNBC (PD-L1+), FDA Decision” | Deck · Aug 4, 2026 | Est. Nov 7, 2026 half midpoint | — |
| GILD | Trodelvy ASCENT-GYN in 2L+ advanced endometrial cancer | 2H 2026 “ASCENT-GYN, 2L+ Advanced Endometrial Cancer, Phase 3 Update” | Deck · Aug 4, 2026 | Est. Nov 7, 2026 half midpoint | — |
| GLUE | MRT-2359 Phase 1/2 expansion arm with enzalutamide in advanced CRPC | by the end of 2026 “Update on the initial Phase 1/2 expansion arm exploring MRT-2359 in combination with enzalutamide in advanced CRPC by the end of the year.” | PR · Aug 6, 2026 | — | — |
| GLUE | second-generation NEK7-directed molecular glue degrader | H2 2026 “Submit an IND application for a second-generation NEK7-directed MGD in H2 2026.” | PR · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | — |
| GMAB | EPKINLY EPCORE DLBCL-2 frontline interim Phase 3 | Q4 2026 “Finally, for EPKINLY, we anticipate that top-line data from the frontline EPCORE DLBCL-2 study, which will be based on an interim analysis, will also be available in the fourth qua” | Call · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| GMAB | Rina-S Rina-S Phase 2 and Phase 3 RAINFOL datasets in platinum-resistant ovarian cancer | Q4 2026 “For Rina-S, we anticipate both phase II and phase III platinum-resistant ovarian cancer datasets will be available in the fourth quarter.” | Call · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| GNLX | Olvi-Vec Phase 3 OnPrime/GOG-3076 registrational trial of Olvi-Vec in platinum-resistant/refractory ovarian cancer · NCT05281471 | 2H 2026 “Topline data from Phase 3 OnPrime/GOG-3076 ovarian cancer registrational trial of Olvi-Vec expected in 2H26” | PR · Aug 13, 2026 | Jan 12 - Feb 23 | Guide earlier than CT.gov |
| GOSS | seralutinib NDA filing acceptance decision (PAH) | late 2026 “The FDA will determine whether to accept the NDA for filing following its initial review of the application, which the Company anticipates could occur later this year.” | PR · Sep 23, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| GPCR | aleniglipron Phase 2 Body Composition · NCT07169942 | Q4 2026 “Phase 2 Body Composition clinical trial (NCT07169942): Results from a 44-week study evaluating aleniglipron's effects on body fat and overall body composition.” | PR · Sep 8, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| GPCR | aleniglipron Phase 2 T2DM · NCT07400588 | Q4 2026 “Phase 2 T2DM clinical trial (NCT07400588): Results in adults living with T2DM and obesity or overweight.” | PR · Sep 8, 2026 | Now - Nov 24, 2026 | On track |
| GPCR | aleniglipron Phase 1 SWITCH | Q4 2026 “Phase 1 SWITCH clinical trial: Results evaluating the transition from approved injectable GLP-1 medicine to once-daily oral aleniglipron.” | PR · Sep 8, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| GSK | neladalkib PDUFA (NSCLC) | H2 2026 “neladalkib (PDUFA H2 2026)” | PR · Jul 28, 2026 | Est. Nov 7, 2026 half midpoint | — |
| GTBP | GTB-3650 Phase 1 dose escalation | 2H 2026 “The ongoing Phase 1 dose escalation study is evaluating GTB-3650 for relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leuke” | PR · Aug 14, 2026 | Est. Nov 7, 2026 half midpoint | — |
| GTBP | GTB-5550 Phase 1 basket trial (B7-H3 solid tumors) · NCT07541573 | 2H 2026 “Enrollment in Cohort 1 is complete and enrollment in Cohort 2 is in progress. The Company expects to provide an update in the 2H 2026.” | PR · Aug 14, 2026 | Est. Nov 7, 2026 half midpoint | — |
| HCWB | HCW9302 Phase 1 alopecia areata monotherapy | Q4 2026 “The Company remains on track for a full Phase 1 clinical data readout in the fourth quarter of 2026.” | PR · Aug 14, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| HRMY | BP-205 Phase 1 MAD | Q4 2026 “Multiple ascending dose (MAD) data in healthy volunteers expected in Q4” | PR · Aug 4, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| HROW | IHEEZO QUELL trial | Q4 2026 “Topline data from QUELL, a prospective, randomized, multicenter clinical trial evaluating IHEEZO in patients undergoing intravitreal injections, are expected in the fourth quarter ” | PR · Aug 10, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| HROW | NATACYN investigator-initiated study | Q4 2026 “The first patients were enrolled in an investigatorinitiated clinical study during the second quarter, with topline data expected in the fourth quarter of 2026.” | PR · Aug 10, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| IBRX | ANKTIVA QUILT-2.005 additional study results · NCT02138734 | Q4 2026 “Additional study results are expected to be available in the fourth quarter of 2026.” | PR · Feb 26, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| IBRX | ANKTIVA BLA submission (BCG-naive NMIBC) · NCT02138734 | 2026 “ImmunityBio anticipates submitting a biologics license application (BLA) to the FDA by Q4 2026.” | PR · Feb 26, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| IDYA | darovasertib + crizotinib OptimUM-02 NDA filing | H2 2026 “new drug application (NDA) filing is underway under the realtime oncology review program (RTOR) with completion expected in H2 2026” | PR · Aug 4, 2026 | Est. Nov 7, 2026 half midpoint | — |
| IGC | IGC-AD1 Phase 2 CALMA topline | Q4 2026 “Patient follow-up, database lock, unblinding, and topline analysis are expected to follow, with topline data anticipated in the fourth quarter of 2026.” | PR · Aug 17, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| IMCR | brenetafusp / IMC-P115C Phase 1/2 data presentations | H2 2026 “The Company expects to present Phase 1/2 data from both trials in the second half of 2026.” | Call · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | — |
| IMCR | tebentafusp TEBE-AM Phase 3 topline | end-2026 “The trial is event driven and topline data could come as early as the end of 2026.” | Call · Aug 6, 2026 | — | — |
| IMMP | IMP761 Phase 1 additional updates | H2 CY26 “with additional trial updates expected in H2 CY26.” | Filing · Aug 3, 2026 | Est. Nov 7, 2026 half midpoint | — |
| IMNM | IM-1021 Phase 1 in B-cell lymphoma | 2026 “Immunome expects to present initial lymphoma data for IM-1021 in 2026.” | PR · Aug 11, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| IMUX | vidofludimus calcium Phase 3 ENSURE-1 and ENSURE-2 in relapsing multiple sclerosis | end of 2026 “Our Phase 3 ENSURE trials of vidofludimus calcium in relapsing MS remain on track to report top-line data by the end of 2026” | PR · Aug 11, 2026 | — | — |
| INCY | Ruxolitinib cream (Opzelura) Phase 3 TRuE-HS1 and TRuE-HS2 in mild-to-moderate hidradenitis suppurativa | Q4 2026 “Topline results from the Phase 3 studies (TRuE-HS1 and TRuE-HS2) evaluating ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) are anticipated in the fourth quarte” | PR · Jul 28, 2026 | Nov 20, 2026 - Jan 1, 2027 | On track |
| IOVA | lifileucel (IOV-LUN-202) pivotal NSCLC cohorts | 4Q26 “Enrollment is nearly complete in the pivotal cohorts and program updates are expected in 4Q26. A supplemental Biologics License Application (sBLA) submission is planned in 2027.” | PR · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| IPHA | monalizumab Phase 3 PACIFIC-9 in unresectable Stage III NSCLC | H2 2026 “Enrollment in the trial is complete, and data readout is expected in H2 2026.” | PR · Sep 16, 2026 | Est. Nov 7, 2026 half midpoint | — |
| IPSC | CNTY-813 first-in-human in type 1 diabetes | IND Q4 2026; data H2 2027 “We plan to submit an IND as early as the fourth quarter of this year and anticipate initial clinical data in the second half of 2027.” | PR · Mar 12, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| IVA | lanifibranor Phase 3 NATiV3 in MASH | Q4 2026 “Inventiva expects to report topline results from NATiV3 in the fourth quarter of 2026, as previously communicated.” | PR · Sep 2, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| JANX | JANX011 Phase 1 in healthy volunteers | H2 2026 “Initial clinical data from the Phase 1 healthy volunteer study of JANX011 expected to be announced in the second half of 2026.” | PR · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | — |
| JSPR | KP-104 (vensobafusp alfa) Phase 2 basket in rare renal indications | Q4 2026 “KP-104 is currently being evaluated in a Phase 2 basket trial in rare renal indications and interim data from Stage 1 of the trial is expected in the fourth quarter of 2026.” | PR · Aug 14, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| KOD | KSI-101 (PEAK Pivotal Analysis 1) PEAK Phase 3, Pivotal Analysis 1 (first 300-patient cohort) in macular edema secondary to inflammation · NCT06990399 | December 2026 “We remain on track for September 2026 DAYBREAK Phase 3 topline results evaluating both Zenkuda and KSI-501 in treatment-naive wet AMD, followed by December 2026 PEAK Phase 3 Pivota” | PR · Aug 13, 2026 | — | — |
| KPRX | KIO-104 KLARITY Phase 2 in macular edema due to retinal inflammation | late 2026 “We expect to report initial clinical data in late 2026.” | PR · Aug 7, 2026 | Dec 13, 2026 - Jan 24, 2027 | On track |
| KPTI | selinexor SENTRY-2 Phase 2 (60 mg cohort, myelofibrosis) · NCT05980806 | H2 2026 “Topline data from the Phase 2 SENTRY-2 60 mg cohort expected in the second half of 2026.” | PR · Aug 13, 2026 | Est. Nov 7, 2026 half midpoint | — |
| KPTI | selinexor SENTRY Phase 3 in JAKi-naive myelofibrosis | Q4 2026 “Karyopharm expects to receive notice of the FDA's decision on sNDA filing acceptance and, if accepted, the anticipated review timelines in the fourth quarter of 2026, following the” | PR · Aug 31, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| KRYS | KB407 KB407 open-label single-arm study in cystic fibrosis · NCT05504837 | H2 2026 “The Company expects to complete enrollment of approximately five patients and report interim study results before year end.” | PR · Aug 3, 2026 | Est. Nov 7, 2026 half midpoint | — |
| KRYS | KB803 IOLITE registrational Phase 3 in corneal abrasions in dystrophic epidermolysis bullosa · NCT07016750 | Q4 2026 “The Company's registrational, intra-patient, double-blind, de-centralized, placebo-controlled study (IOLITE) with crossover design evaluating KB803 for the treatment and prevention” | PR · Aug 3, 2026 | Jan 12 - Feb 23 | Guide earlier than CT.gov |
| KYMR | KT-621 (BROADEN2) BROADEN2 Phase 2b in atopic dermatitis | year-end 2026 “The earlier than expected completion of enrollment enabled the Company to accelerate its expected topline data readout by six months to year-end 2026, earlier than prior guidance t” | PR · Aug 5, 2026 | — | — |
| KYNB | FG-3246 FG-3246 Phase 2 in metastatic castration-resistant prostate cancer | Q4 2026 “We are advancing FG-3246, a potential first-in-class ADC for the treatment of metastatic castration-resistant prostate cancer, with interim results from the ongoing Phase 2 trial o” | PR · Aug 31, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| KYTX | miv-cel KYSA-8 registrational Phase 2 in stiff person syndrome | Q4 2026 “rolling BLA submission on track for completion in Q4 2026” | PR · Sep 24, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| LKFT | gamgertamig gamgertamig Phase 1b in autoimmune diseases | 2026 “We are looking forward to sharing additional data on this potential first-in-class, best-in-class T-cell engager later this year,” | Filing · Aug 10, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| LRMR | nomlabofusp nomlabofusp open-label study in Friedreich's ataxia | H2 2026 “Following receipt of minutes from a successful Type B multidisciplinary pre-BLA meeting with the Food and Drug Administration (FDA), the first module of our rolling Biologics Licen” | Filing · Aug 4, 2026 | Est. Nov 7, 2026 half midpoint | — |
| LXRX | ZYNQUISTA (sotagliflozin) STENO1 open-label study in type 1 diabetes | Q4 2026 “the company's New Drug Application (NDA), which Lexicon anticipates will occur in the fourth quarter of 2026 based on current estimated timing of data collection.” | PR · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| LYEL | LYL273 LYL273 U.S. Phase 1 in 3L+ relapsed/refractory mCRC | H2 2026 “Additional data from the U.S. Phase 1 trial of LYL273 in 3L+ patients with relapsed/refractory mCRC and End-of-Phase 1 FDA meeting are expected in the second half of 2026” | PR · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | — |
| LYEL | ronde-cel PiNACLE pivotal Phase 2 in 3L+ LBCL | H2 2026; mid-2027 “PiNACLE pivotal clinical trial evaluating rondecel in 3L+ patients with LBCL on track to report additional data in second half of 2026, with pivotal data expected mid-2027 and BLA ” | PR · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | — |
| MBIO | MB-109 MB-109 investigator-sponsored Phase 1 study at City of Hope | Q4 2026 (trial initiation, under exploration) “We are exploring with COH and Nationwide the possibility of initiating the MB-109 clinical trial for GBM and highgrade astrocytoma as an investigatorsponsored singleinstitution stu” | Filing · Aug 5, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| MBX | MBX 4291 Phase 1 MAD study in obesity | Q4 2026 “Now we look forward to dosing the first patients in our Phase 3 trial of canvuparatide this quarter and to presenting 12-week multiple ascending dose (MAD) data for MBX 4291 in the” | PR · Aug 6, 2026 | Dec 11, 2026 - Jan 22, 2027 | On track |
| MGNX | MGC028 Phase 1 dose-escalation study | Late 2026 “The dose escalation study of MGC028 is ongoing and the Company anticipates providing an update with preliminary clinical results in late 2026.” | PR · Aug 13, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| MGTX | Bota-vec Global regulatory filings in X-linked retinitis pigmentosa | 2026 “Anticipate submission of global regulatory filings for approval of bota-vec in 2026 and potential BLA filing for AAV2-hAQP1 in mid-2027” | PR · Aug 13, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| MGX | MGX-001 Global clinical program (IND submission) | Q4 2026 “The Company remains on track to submit an IND application in the fourth quarter of 2026 for the global clinical program, and subject to regulatory clearance, initiate clinical tria” | PR · Aug 10, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| MIRM | Brelovitug Phase 3 AZURE-4 study in chronic hepatitis delta virus | Q4 2026 “Brelovitug AZURE-1 and AZURE-4 Phase 3 studies in chronic hepatitis delta virus (HDV) topline results expected in Q3 and Q4 2026, respectively.” | PR · Aug 5, 2026 | Est. Nov 15, 2026 quarter midpoint | Slipped |
| MNKD | Ralinepag DPI (MNKD-1501) MNKD-1501 IND filing | By year-end 2026 “On track for IND filing by year end.” | PR · Aug 5, 2026 | — | — |
| MNOV | MN-166 (ibudilast) Phase 2b/3 COMBAT-ALS trial | End of 2026 “MediciNova expects to report topline results from the double-blind portion of the study by the end of 2026.” | PR · Sep 24, 2026 | — | — |
| MRNA | mRNA-3927 Registrational study in propionic acidemia | 2026 “In rare diseases, our propionic acidemia, or PA program, is fully enrolled in its registrational study, and we expect data from the study in 2026.” | Call · Jul 31, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| MSLE | SAT-3247 BASECAMP (SAT-3247-CL-201) | Q4 2026 “We expect to release clinical data from the BASECAMP pediatric trial in the fourth quarter, which will help to inform our continued development and regulatory strategies.” | PR · Aug 13, 2026 | Now - Nov 22, 2026 | On track |
| MTVA | DA-1726 Phase 1 Part 3 study in obesity | Q4 2026 “Most recently, all active patients in both cohorts of our ongoing Phase 1 Part 3 study successfully reached the highest planned dose levels of 48 mg and 64 mg, representing an impo” | PR · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| NAMS | Obicetrapib Phase 3 RUBENS study in type 2 diabetes and metabolic syndrome | Year-end 2026 “Topline data from RUBENS Phase 3 expected by year-end 2026” | PR · Aug 5, 2026 | — | — |
| NBP | VIS-101 Phase 2b program in neovascular AMD | H2 2026 “H2 2026: Initiate Phase 2b program in nAMD” | PR · Aug 20, 2026 | Est. Nov 7, 2026 half midpoint | — |
| NCNA | NUC-7738 Phase 2 NuTide:701 expansion study | Later in 2026 “Based on the data presented to date, we remain confident in the benefit NUC-7738 may offer these patients, and we remain on track to present final data from this study later this y” | PR · Aug 13, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| NMRA | NMRA-511 NMRA-511 MAD expansion cohort in healthy elderly participants | Q4 2026 “Neumora plans to report data from a MAD expansion cohort evaluating higher doses of NMRA-511 in healthy elderly participants in the fourth quarter of 2026 and to initiate a Phase 2” | PR · Aug 14, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| NMRA | NMRA-898 NMRA-898 Phase 1 MAD study | 2H 2026 “Neumora is conducting a MAD study with NMRA-898 in healthy volunteers and patients with stable schizophrenia and expects to report data from the study in the second half of 2026.” | PR · Aug 14, 2026 | Est. Nov 7, 2026 half midpoint | — |
| NRIX | bexobrutideg (NX-5948) Phase 1a/1b NX-5948-301 updates in relapsed/refractory CLL · NCT05131022 | throughout 2026 “Updated data from this study are anticipated to be presented at upcoming medical meetings throughout 2026.” | PR · Jul 9, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| NRSN | PrimeC PrimeC Health Canada New Drug Submission | December 2026 “NeuroSense has completed the pre-New Drug Submission process with Health Canada and is preparing a New Drug Submission for PrimeC, which the Company continues to target for Decembe” | PR · Aug 31, 2026 | — | — |
| NVCT | NXP900 Phase 1b of NXP900 + osimertinib in EGFR+ NSCLC | Q4 2026 “the clinical trial evaluating the combination of NXP900 plus osimertinib (Tagrisso™) in patients with NSCLC EGFR+ who initially responded to, and later progressed on, osimertinib, ” | PR · Aug 4, 2026 | Jan 12 - Feb 23 | Guide earlier than CT.gov |
| NVO | CagriSema CagriSema FDA decision for weight management | Q4 2026 “Novo filed a New Drug Application with the U.S. Food and Drug Administration in December 2025 for CagriSema for weight management, demonstrating the company's commitment to lasting” | PR · Sep 21, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| NVS | ianalumab VAYHIT1 Phase 3 first-line ITP readout | 2H 2026 “We're on track for the ITP first-line readout in the second half of 2026, the SLE and lupus nephritis phase III readouts in 2027, and the systemic sclerosis phase II readout as wel” | Call · Jul 21, 2026 | Est. Nov 7, 2026 half midpoint | — |
| OCS | licaminlimab PREDICT-1 registrational trial topline in dry eye disease | around year-end 2026 “with Licaminlimab PREDICT-1 genotypebased trial planned site activations complete and over 45% of patients enrolled, we expect to report topline results around yearend.” | Call · Aug 6, 2026 | Jan 12 - Feb 23 | Guide earlier than CT.gov |
| OCS | privosegtor IND submission for acute MS relapses | Q4 2026 “Oculis anticipates an IND submission for the treatment of acute MS relapses in the fourth quarter of 2026.” | Call · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| OCUL | AXPAXLI (OTX-TKI) Wet-AMD NDA submission | Q4 2026 “New Drug Application (NDA) submission for AXPAXLI in wet AMD planned for Q4 2026, with FDA alignment confirmed in May 2026 Type C meeting minutes.” | PR · Aug 3, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| OGEN | ONP-002 Australian Phase 2a concussion trial data | Q4 2026 “Oragenics continues to target a Phase IIa data readout in the fourth quarter of 2026.” | PR · Jul 7, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ONC | sonrotoclax (taca) Accelerated-approval submission in relapsed/refractory CLL | by year-end 2026 “We remain on track for potential accelerated approval submission of taca in relapsed/refractory CLL by the end of this year.” | Call · Aug 5, 2026 | Now - Dec 15, 2026 | On track |
| ORIC | enozertinib (ORIC-114) 1L EGFR exon 20 insertion monotherapy and SC amivantamab combination data | 2H 2026 “2H 2026: 1L EGFR exon 20 insertion monotherapy data and combination data with SC amivantamab” | PR · Aug 3, 2026 | Now - Nov 24, 2026 | Slipped |
| ORKA | ORKA-001 EVERLAST-B Phase 2 of ORKA-001 in moderate-to-severe plaque psoriasis | Q4 2026 “EVERLAST-B fully enrolled ahead of schedule, with Week 16 data now expected in 4Q 2026” | PR · Aug 10, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ORKA | ORKA-001 EVERLAST-A Week 52 data | December 2026 “Oruka plans to share longer-term data from EVERLAST-A, including efficacy at Week 52 for all patients, in December 2026.” | PR · Sep 23, 2026 | — | — |
| OSTX | OST-HER2 BLA completion and Type B pre-BLA meeting | Q4 2026 “The Company expects to hold its previously disclosed invited Type B Pre-BLA meeting with FDA in the fourth quarter of 2026 following the submission of the clinical section, inclusi” | PR · Sep 17, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| OVID | OV329 exploratory photosensitivity proof-of-mechanism study | near year-end 2026 “The Company intends to test three doses of OV329, including 5, 7 and 9 milligrams, and anticipates results near year end 2026.” | PR · Aug 13, 2026 | — | — |
| PBLS | zolucatetide Phase 1/2 study in desmoid tumors, more mature clinical data | Q4 2026 “Expect to present more mature clinical data from the ongoing Phase 1/2 study in desmoid tumors during the fourth quarter of 2026.” | PR · Aug 13, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| PBLS | zolucatetide FDA engagement to align on planned registrational Phase 3 trial | Q4 2026 “Expect to engage with the U.S. Food and Drug Administration (FDA) during the fourth quarter of 2026 to discuss and align on the planned registrational Phase 3 trial.” | PR · Aug 13, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| PBYI | alisertib ALISCA-Breast1 Phase 2, updated interim data with longer-term follow-up | Q4 2026 “We will also be updating interim data from the ALISCA-Breast1 trial, including longer-term patient follow-up in the fourth quarter of this year.” | Call · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| PCRX | PCRX-201 ASCEND Phase 2 Part A topline in knee osteoarthritis | by end of 2026 “Enrollment in Part A concluded in June, with topline data expected by the end of 2026.” | PR · Aug 4, 2026 | — | — |
| PCRX | ZILRETTA Phase 3 registration study in shoulder osteoarthritis topline | later in 2026 “The company expects to report topline results later this year. If the study is successful, ZILRETTA could be the first product with an on-label indication for OA pain of the should” | PR · Apr 30, 2026 | Est. Nov 7, 2026 guidance midpoint | — |
| PFE | mevrometostat MEVPRO-1 Phase 3 in post-abiraterone metastatic hormone-resistant prostate cancer, first readout | Q4 2026 “Each of these studies is event-driven with the first readout expected for MEVPRO-1 in the fourth quarter based on the current event rate.” | Call · Aug 4, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| PGEN | PRGN-2009 head and neck program Phase 2 in newly diagnosed HPV-positive oropharyngeal cancer, data update | Q4 2026 “The company is looking forward to providing a data update in the head and neck program in the Fourth Quarter of this year.” | PR · Aug 25, 2026 | Dec 23, 2026 - Feb 3, 2027 | On track |
| PHAT | vonoprazan (VOQUEZNA) pHalcon-EoE-201 Phase 2 in eosinophilic esophagitis · NCT06851559 | Q4 2026 “Topline results for the double-blind 12-week treatment portion of the study are expected in Q4 of 2026.” | PR · Jun 23, 2026 | Nov 12 - Dec 24 | On track |
| PPCB | PRP Clinical Trial Application submission for first-in-human Phase 1b study in advanced solid tumors | Q4 2026 “The documents will be provided to Investigators in Clinical Trial Centers located across Australia for the world-first study to obtain detailed and thorough feedback as part of a f” | PR · Aug 18, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| PRAX | relutrigine (PRAX-562) EMERALD Phase 3 registrational study in broad DEEs | Q4 2026 “Looking ahead, we expect topline results from the POWER1 study of vormatrigine in focal epilepsy this quarter, followed by the EMERALD readout in broad DEEs in the fourth quarter.” | PR · May 7, 2026 | Est. Nov 15, 2026 quarter midpoint | Slipped |
| PTHS | CT2000 Phase 1b/2a clinical trial in eye pain, results | by end of 2026 “Results are anticipated at the end of 2026.” | PR · Mar 31, 2026 | — | — |
| RADX | RAD 402 Phase 1 in advanced prostate cancer · NCT07259213 | 2H 2026 “On track to share data from first two dose levels in 2H 2026.” | PR · Mar 27, 2026 | Est. Nov 7, 2026 half midpoint | — |
| RANI | RT-114 Phase 1 dose-expansion cohort | by end of 2026 “We have continued to advance the program in the clinic, with additional data from the dose expansion cohort expected by the end of 2026.” | PR · Aug 13, 2026 | Jan 12 - Feb 23 | Guide earlier than CT.gov |
| RARE | UX701 Cyprus2+ pivotal study dose-finding stage | Q4 2026 “Enrollment is complete for the fourth cohort in the ongoing, dose-finding stage of the pivotal Cyprus2+ study. Data from this stage are expected in the fourth quarter of 2026.” | PR · Aug 4, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| RCUS | casdatifan PEAK-1 Phase 3 enrollment completion and PEAK-20 Phase 3 initiation in ccRCC | Q4 2026 “Arcus expects to complete enrollment in PEAK-1 and to initiate the Phase 3 PEAK-20 study in first-line metastatic ccRCC by year-end 2026.” | PR · Sep 22, 2026 | Est. Nov 15, 2026 quarter midpoint | Slipped |
| RDY | abatacept IV biosimilar (DRL_AB) FDA review action date for abatacept IV biosimilar | December 2026 “The timing is, launch upon approval. Right now, the goal date is December, so obviously, we hope for that. But we need to see whether we will get additional queries. And if not, we” | Filing · Jul 29, 2026 | — | — |
| REPL | RP2 RP2 monotherapy cohort in HCC (preliminary data) | by end of 2026 “The protocol has been amended to include RP2 as monotherapy and we plan to release preliminary HCC data by the end of 2026.” | Filing · 2026-09 | — | — |
| RFL | Trappsol Cyclo Trappsol Cyclo NDA submission | 2H 2026 “Additionally, the Company has completed a pre-New Drug Application (“NDA”) meeting with the U.S. Food and Drug Administration (“FDA”) and expects to submit an NDA for Trappsol® Cyc” | Deck · Jun 11, 2026 | Est. Nov 7, 2026 half midpoint | — |
| RGNX | RGX-314 (surabgene lomparvovec / ABBV-RGX-314) ATMOSPHERE and ASCENT pivotal trials in wet AMD (subretinal delivery) | Q4 2026 “Topline data from pivotal subretinal wet AMD studies, ATMOSPHERE and ASCENT, expected in Q4 2026.” | PR · Aug 6, 2026 | Nov 12 - Dec 24 | On track |
| RIGL | R289 Phase 1b dose-expansion in R/R lower-risk MDS (preliminary data) | by year-end 2026 “We are also advancing the development of R289 in our ongoing Phase 1b study in patients with R/R lower-risk MDS, and remain on track to complete enrollment in the dose expansion ph” | Filing · Aug 4, 2026 | — | — |
| RLMD | NDV-01 NDV-01 IND filing ahead of Phase 3 RESCUE registrational program | by year-end 2026 “Advancing NDV-01 toward IND filing expected by year-end 2026 with GMP manufacturing of clinical trial material underway. Initiation of the Phase 3 RESCUE registrational program upo” | PR · Aug 6, 2026 | — | — |
| RLMD | sepranolone sepranolone IND filing ahead of Phase 2 proof-of-concept in Prader-Willi Syndrome | by year-end 2026 “Sepranolone IND filing expected by year-end 2026 and initiation of Phase 2 proof-of-concept study in Prader-Willi Syndrome upon IND clearance.” | PR · Aug 6, 2026 | — | — |
| RNTX | LTI-03 Phase 2 RENEW trial in IPF (interim data) | 2H 2026 “Enrollment is tracking ahead of schedule and the Company remains on track to report interim data in the second half of 2026.” | PR · Aug 14, 2026 | Est. Nov 7, 2026 half midpoint | — |
| ROIV | brepocitinib Phase 3 study in non-infectious uveitis (NIU) | 2H 2026 “Priovant expects the commercial launch of brepocitinib in DM by the end of September 2026 and topline data from the Phase 3 study in NIU and Phase 3 study in CS in the second half ” | PR · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | — |
| RZLT | ersodetug upLIFT Phase 2b in tumor-HI (topline) | before end of 2026 “Enrollment is in progress and topline results are expected before the end of 2026.” | PR · Sep 24, 2026 | — | — |
| SLS | SLS009 (tambiciclib) Phase 2 in newly diagnosed frontline AML · NCT04588922 | Q4 2026 “with topline data expected in the fourth quarter of 2026.” | PR · Aug 11, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| SMMT | ivonescimab (HARMONi-3, squamous PFS) HARMONi-3 Phase 3 in first-line squamous NSCLC (primary PFS analysis; planned early interim OS analysis) · NCT05899608 | H2 2026 “The number of PFS events needed in the squamous cohort for the primary analysis is expected to be reached in the second half of 2026, and a planned early interim analysis for OS is” | PR · Jul 23, 2026 | Est. Nov 7, 2026 half midpoint | — |
| SNDX | axatilimab (frontline cGVHD) Phase 2 in frontline chronic graft-versus-host disease (cGVHD) | Q4 2026 “Topline data expected in 4Q26 from Phase 2 trials of axatilimab in IPF and frontline cGVHD” | PR · Aug 4, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| SNY | Sarclisa (isatuximab) Phase 3 in transplant-eligible multiple myeloma | remainder of 2026 “For the remainder of this year, we expect the final phase III readout for Sarclisa in transplant-eligible multiple myeloma” | Call · Jul 30, 2026 | Est. Nov 15, 2026 guidance midpoint | — |
| SPRB | TA-ERT (tralesinidase alfa) MPS IIIB (Sanfilippo syndrome type B), BLA submission | Q4 2026 (BLA submission) “BLA submission for TA-ERT for the treatment of MPS IIIB anticipated in the fourth quarter of 2026.” | PR · Aug 12, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| SRPT | SRP-1001 Phase 1/2 in facioscapulohumeral muscular dystrophy (FSHD), MAD cohort · NCT06131983 | H2 2026 “Readouts from our MAD cohorts of our ongoing phase 1/2 studies in DM1 and FSHD remain on track for 2H 2026.” | PR · Aug 5, 2026 | Est. Nov 7, 2026 half midpoint | — |
| SRPT | SRP-1003 Phase 1/2 in myotonic dystrophy type 1 (DM1), MAD cohort · NCT06138743 | H2 2026 “Readouts from our MAD cohorts of our ongoing phase 1/2 studies in DM1 and FSHD remain on track for 2H 2026.” | PR · Aug 5, 2026 | Est. Nov 7, 2026 half midpoint | — |
| SRRK | SRK-439 Phase 1 in healthy volunteers · NCT07444294 | H2 2026 “A Phase 1 study in healthy volunteers is underway, and topline data are expected in the second half of 2026.” | PR · Jan 12, 2026 | Est. Nov 7, 2026 half midpoint | — |
| SVRA | molgramostim (MOLBREEVI, UK MAA) aPAP, UK MHRA MAA under review | Q4 2026 “MOLBREEVI MAAs Under Review by the EMA and the U.K.'s MHRA; Decisions Expected in Q1 2027 and Q4 2026, respectively” | PR · Aug 12, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| SYRE | SPY072 (PsA) SKYWAY Phase 2 in psoriatic arthritis · NCT07148414 | Q4 2026 “Remain on track for 6 proof-of-concept Phase 2 readouts in 2026, with the rheumatoid arthritis (“RA”) sub-study in SKYWAY and the SPY003 Part A data from SKYLINE expected in Septem” | PR · Aug 4, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| SYRE | SPY072 (axSpA) SKYWAY Phase 2 in axial spondyloarthritis · NCT07148414 | Q4 2026 “Remain on track for 6 proof-of-concept Phase 2 readouts in 2026, with the rheumatoid arthritis (“RA”) sub-study in SKYWAY and the SPY003 Part A data from SKYLINE expected in Septem” | PR · Aug 4, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| TARA | IV Choline Chloride THRIVE-3 Phase 3 in patients on long-term parenteral support, dose-confirmation interim | Q4 2026 “We anticipate reporting interim results from the dose-confirmation portion of the trial in the fourth quarter of 2026.” | Filing · Aug 11, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| TARA | TARA-002 (STARBORN-1) STARBORN-1 Phase 2 in lymphatic malformations | Q4 2026 (enrollment completion and update) “We intend to provide an update on STARBORN-1 and complete enrollment of STARBORN-1 in the fourth quarter of 2026.” | Filing · Aug 11, 2026 | Jan 12 - Feb 23 | Guide earlier than CT.gov |
| TEVA | TEV-'749 olanzapine long-acting injectable FDA regulatory decision | Q4 2026 “A PDUFA decision from the FDA is expected for TEV-'749 in Q4 2026.” | PR · Sep 18, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| TNGX | TNG456 Phase 1/2 of TNG456 (brain-penetrant MTAP-selective PRMT5 inhibitor) in glioblastoma and other cancers | 2H 2026 “Release initial TNG456 data in glioblastoma and other cancers in 2H 2026” | PR · Aug 11, 2026 | Est. Nov 7, 2026 half midpoint | — |
| TNYA | TN-201 MyPEAK-1 Phase 1b/2 in MYBPC3-associated hypertrophic cardiomyopathy (additional interim data; pivotal regulatory alignment update) | Q4 2026 “Tenaya plans to report additional interim data from the MyPEAK-1 clinical trial in the fourth quarter of 2026. Tenaya is pursuing alignment with regulatory authorities on late-stag” | PR · Aug 5, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| TNYA | TN-401 RIDGE-1 Phase 1b/2 in PKP2-associated arrhythmogenic right ventricular cardiomyopathy (additional interim data; pivotal regulatory alignment update) · NCT06228924 | Q4 2026 “Tenaya expects to report additional interim data from the RIDGE-1 clinical trial in the fourth quarter of 2026. Tenaya is currently engaging with regulators on late-stage pivotal t” | PR · Aug 5, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| TRDA | ENTR-601-44 ELEVATE-44-201 Phase 1/2 in Duchenne muscular dystrophy, Cohort 1 (6 mg/kg) open-label period | by year-end 2026 “The Company is on track to report data from the Cohort 1 (6 mg/kg) open-label period of the study by year-end 2026.” | PR · Aug 5, 2026 | — | — |
| TRDA | VX-670 (Vertex Pharmaceuticals) GALILEO Phase 1/2 in myotonic dystrophy type 1 (partner-controlled; Vertex) | 2H 2026 “Vertex is on track to complete dosing and report results in the second half of 2026.” | PR · Aug 5, 2026 | Est. Nov 7, 2026 half midpoint | — |
| TVRD | TTI-101 Phase 1b/2 in hepatocellular carcinoma (HCC) · NCT05440708 | Q4 2026 “4Q 2026: TTI-101 Phase 1b/2 HCC topline data.” | PR · Aug 14, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| VERA | TRUTAKNA (atacicept) supplemental BLA submission for full approval in IgA nephropathy | Q4 2026 “Plan to submit supplemental BLA to the U.S. Food and Drug Administration (FDA) for full approval in Q4 2026.” | PR · Sep 15, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| VIR | elebsiran plus tobevibart Phase 3 ECLIPSE 1 trial of elebsiran plus tobevibart in chronic hepatitis delta | Q4 2026 “Topline data from the Phase 3 ECLIPSE 1 trial are expected in the fourth quarter of 2026.” | PR · Aug 5, 2026 | Jan 12 - Feb 23 | Guide earlier than CT.gov |
| VNDA | tradipitant Phase 3 NEREUS trial of tradipitant in vomiting induced by GLP-1 therapy | Q4 2026 “Results for three Phase III clinical trials expected by end of 2026: NEREUS™ (tradipitant) in vomiting in GLP-1, VQW-765 in social anxiety disorder, HETLIOZ® (tasimelteon) in delay” | PR · Aug 5, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| VRDN | TSHR antibody (unnamed) TSHR program IND submission for thyroid eye disease and Graves’ disease | Q4 2026 “Viridian plans to submit an Investigational New Drug (IND) application in Q4 2026 and expects to develop this program in TED and Graves’ disease.” | PR · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| VRDN | VRDN-008 Phase 1 healthy-volunteer study of VRDN-008: data | 2H 2026 “VRDN-008 phase 1 clinical trial in healthy volunteers is ongoing. Data remains on track for 2H 2026.” | PR · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | — |
| VYGR | VY7523 Phase 1 multiple ascending dose trial of VY7523 in Alzheimer’s disease: tau PET imaging efficacy data | Q4 2026 “VY7523 (anti-tau antibody): Voyager expects tau positron emission tomography (PET) imaging efficacy data in Q4 2026 from the ongoing multiple ascending dose (MAD) clinical trial in” | PR · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| WVE | WVE-008 CTA filing for WVE-008 | 2H 2026 “A clinical trial application (CTA) filing for WVE-008 is on track for the second half of 2026.” | PR · Jul 30, 2026 | Est. Nov 7, 2026 half midpoint | — |
| XRTX | XRx-026 IND submission for XRx-026 for gout | Q4 2026 “Recent drug development team activities include preparation of a new IND for submission to the FDA in the fourth quarter of 2026.” | PR · Sep 18, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ZBIO | ZB021 Phase 1 trial of ZB021 in healthy volunteers: initial data | Q4 2026 “These data are expected by year-end 2026.” | PR · Aug 13, 2026 | Est. Nov 15, 2026 quarter midpoint | — |
| ZBIO | obexelimab Phase 2 SunStone trial of obexelimab in systemic lupus erythematosus: topline results · NCT06559163 | Q4 2026 “Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) topline results expected in 4Q 2026: Zenas anticipates reporting topline overall and biomarker population results in th” | PR · Aug 13, 2026 | Now - Nov 24, 2026 | On track |
| ZLAB | ZL-1503 Phase 1/1b study of ZL-1503 in healthy volunteers: SAD initial first-in-human data | 2H 2026 “Report initial first-in-human data from the SAD portion of the global Phase 1/1b study in healthy volunteers, including pharmacokinetics (PK), half-life, pharmacodynamic biomarkers” | PR · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | — |
| ZURA | tibulizumab Phase 2 TibuSHIELD trial of tibulizumab in hidradenitis suppurativa: topline data | Q4 2026 “Topline data are anticipated in the fourth quarter of 2026.” | PR · Aug 11, 2026 | Dec 13, 2026 - Jan 24, 2027 | Pulled forward |
| ZYME | pasritamig Phase 1b trial of pasritamig in combination with JNJ-9401 in advanced prostate cancer (J&J): data presentation | 2H 2026 “Johnson and Johnson Innovative Medicine (J&J) expect to present Phase 1b clinical data for pasritamig, a first-in-class bispecific antibody against KLK2, in combination with JNJ-94” | PR · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | — |
| DYN | z-rostudirsen BLA review for exon 51 DMD | January 21, 2027 (PDUFA) “Dyne's BLA was accepted for review by the FDA in July 2026, with Priority Review granted (Prescription Drug User Fee Act (PDUFA) target action date set for January 21, 2027).” | PR · Jul 29, 2026 | — | — |
| PRAX | ulixacaltamide HCl NDA for ulixacaltamide HCl, PDUFA date | January 29, 2027 “PDUFA date of January 29, 2027.” | PR · Aug 6, 2026 | — | — |
| AVIR | bemnifosbuvir + ruzasvir (BEM/RZR) C-FORWARD Phase 3 in chronic HCV, conducted outside North America · NCT07037277 | early Q1 2027 “Topline results are expected in early Q1 2027 and will provide additional efficacy data across a broader range of HCV genotypes more commonly found outside of the US and Canada.” | PR · Aug 12, 2026 | Jan 12 - Feb 23 | Pulled forward |
| PEPG | PGN-EDODM1 FREEDOM open-label extension update | by early January 2027 “Update from the OLE study is expected by early January.” | PR · Aug 6, 2026 | — | Slipped |
| TECX | TX45 APEX Phase 2 in pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) | early Q1 2027 “The global, randomized, placebo-controlled 24-week APEX Phase 2 trial is ongoing, evaluating subcutaneous TX45 in patients with PH-HFpEF, including an enriched population with comb” | PR · Aug 6, 2026 | — | — |
| BLTE | tinlarebant NDA PDUFA for Stargardt disease type 1 | February 12, 2027 “The FDA had accepted the NDA submission and granted Priority Review, with an assigned PDUFA target action date of February 12, 2027.” | PR · Aug 12, 2026 | — | — |
| ARQT | ZORYVE cream 0.05% sNDA to expand indication to infants 3-24 months with atopic dermatitis | 2027-02-23 “FDA accepted sNDA for ZORYVE cream 0.05% to expand indication to include infants with mild to moderate atopic dermatitis aged 3 to 24 months and set target action date of February ” | PR · Aug 5, 2026 | — | — |
| ANAB | Jemperli (dostarlimab) AZUR-1 pivotal Phase 2 in dMMR/MSI-H locally advanced rectal cancer | February 2027 “The FDA has assigned a PDUFA action date of February 2027” | PR · Sep 21, 2026 | — | — |
| APMD | AD109 (Oxnimbi) Obstructive sleep apnea, FDA PDUFA | 2027-02-28 “The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of February 28, 2027.” | PR · Sep 8, 2026 | — | — |
| BMRN | vosoritide (VOXZOGO) sNDA PDUFA for full approval in children with achondroplasia | February 28, 2027 “In July, BioMarin announced that the FDA accepted its sNDA for full approval of VOXZOGO in children with achondroplasia, with a Prescription Drug User Fee Act (PDUFA) target action” | PR · Aug 6, 2026 | — | — |
| MBRX | Annamycin (naxtarubicin) Pivotal MIRACLE trial Part A in AML | December 2026 to February 2027 “Enrollment remains on track to reach the 90-patient milestone in September with the data readout in the December 2026 to February 2027 timeframe.” | PR · Aug 14, 2026 | — | — |
| EXEL | zanzalintinib metastatic colorectal cancer (zanzalintinib + atezolizumab) | March 3, 2027 “Today, Exelixis, Inc. (Exelixis) announced that on September 10, 2026, the U.S. Food and Drug Administration (FDA) notified Exelixis that it had extended the review period for Exel” | Filing · Sep 11, 2026 | — | Slipped |
| NTLA | lonvoguran ziclumeran (NTLA-2002) lonvo-z BLA PDUFA for hereditary angioedema | March 10, 2027 “the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lonvo-z and granted the BLA Priority Review with a PDUFA target action date of ” | PR · Sep 8, 2026 | — | — |
| AIM | Ampligen plus Imfinzi DURIPANC study in pancreatic cancer, topline results · NCT05927142 | Q1 2027 “We anticipate topline results from the DURIPANC study in Q1 2027, followed by a detailed analysis of overall survival in Q3 2027.” | PR · Sep 22, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| AKTS | AKY-1189 NECTINIUM-2 Phase 1b, preliminary data · NCT07020117 | Q1 2027 “Expect preliminary data from the ongoing Phase 1b NECTINIUM-2 clinical trial in the first quarter of 2027.” | PR · Aug 13, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| ALEC | AL137 IND submission | Q1 2027 “The company is targeting an IND submission in Q1 2027 and first-in-human dosing in Australia no later than April 2027.” | PR · Aug 6, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| ANVS | buntanetap Pivotal Phase 3 in Alzheimer’s disease · NCT06709014 | March 2027 “The Company aims to reach the database lock for the 6-month treatment period in December 2026, followed by the top-line symptomatic data announcement in March 2027.” | PR · Sep 23, 2026 | — | — |
| ATYR | efzofitimod EFZO-CONNECT Phase 2 in SSc-ILD | Q1 2027 “Enrollment completed in Phase 2 EFZO-CONNECT™ study of efzofitimod in SSc-ILD; topline results expected in the first quarter of 2027.” | PR · Aug 7, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| AUTL | obe-cel BOBCAT Phase 1 in progressive MS | Q1 2027 “First preliminary results, including safety, PK/PD and biomarker data are planned to be presented at the ACTRIMS Forum in the first quarter of 2027.” | PR · Aug 11, 2026 | Est. Feb 14, 2027 quarter midpoint | Slipped |
| BDRX | eRapa Phase 3 interim futility analysis in familial adenomatous polyposis | Q1 2027 “an interim futility analysis is expected in Q1 2027” | Source · Sep 23, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| BLTE | tinlarebant PHOENIX Phase 3 interim analysis in geographic atrophy | Q1 2027 “GA interim analysis expected first quarter next year, after FDA PDUFA date in February.” | Call · Aug 13, 2026 | Est. Feb 14, 2027 quarter midpoint | Slipped |
| BMEA | icovamenib COVALENT-211 Phase II 26-week primary endpoint topline in insulin-deficient type 2 diabetes · NCT07502495 | Q1 2027 “With COVALENT-211 now fully enrolled and our Phase II trial COVALENT-212 expected to complete enrollment over the coming months before year end, we remain focused on execution as w” | PR · Aug 24, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| CANF | piclidenoson Phase 3 psoriasis trial interim results | Q1 2027 “Results are expected during Q1 2027.” | PR · Sep 8, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| CBIO | CR-001 ASCEND Phase 1/2 global trial proof-of-concept | Q1 2027 “Proof-of-concept clinical data from the ASCEND trial of CR-001 in the first quarter of 2027, including initial safety, pharmacokinetics, pharmacodynamics and preliminary antitumor ” | PR · Jul 30, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| CBIO | CR-003 China Phase 1/2 trial in advanced solid tumors proof-of-concept | Q1 2027 “A Phase 1/2 trial of CR-003 (also known as SKB105) in participants with advanced solid tumors conducted by Kelun-Biotech in China is ongoing and proof-of-concept data are expected ” | PR · Jul 30, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| CGEN | COM701 MAIA-ovarian adaptive platform trial interim analysis, median progression-free survival data · NCT06888921 | Q1 2027 “Our MAIA-ovarian trial in platinum-sensitive ovarian cancer remains on track for the interim analysis with median progression-free survival data expected by the first quarter of 20” | PR · Aug 3, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| CRBP | CRB-701 CRB-701 + Keytruda combination in first-line OPSCC (data) | Q1 2027 “Anticipate reporting CRB-701 + Keytruda combination data in first-line (1L) settings in OPSCC patients in Q1 2027 to support potential further registration-enabling trials in the f” | PR · Aug 6, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| CRVO | neflamapimod Phase 2a trial in nfvPPA · NCT07033481 | October 2026 (ISFTD 12-week biomarker presentation); November 2026 (CTAD biomarker presentations); Q1 2027 (initial topline clinical data) “CervoMed will present 12-week biomarker data from the first eight participants in its ongoing Phase 2a trial in patients with nfvPPA at ISFTD, taking place October 8-11, 2026, in P” | PR · Aug 10, 2026 | Est. Feb 14, 2027 quarter midpoint | Slipped |
| DMAC | DM199 Phase 2/3 ReMEDy2 in acute ischemic stroke · NCT05065216 | Q1 2027 “Enrollment in the Company's Phase 2/3 ReMEDy2 (the ReMEDy2 trial - NCT05065216) trial has surpassed 85% of the 200 participants required to trigger the prespecified interim analysi” | PR · Aug 10, 2026 | Jan 12 - Feb 23 | On track |
| DSGN | DT-216P2 RESTORE-FA in Friedreich ataxia | Q1 2027 “Design expects to provide an update on its registrational plans in the fourth quarter of 2026, with data following 12 weeks of treatment expected in the first quarter of 2027.” | PR · Aug 3, 2026 | Jan 12 - Feb 23 | On track |
| DYN | z-basivarsen Phase 1/2 ACHIEVE registrational expansion cohort in DM1 | Q1 2027 (ACHIEVE REC topline); Q3 2027 (potential BLA submission) “Topline data from the ACHIEVE REC are planned for Q1 2027 to support a potential BLA submission for U.S. Accelerated Approval in Q3 2027.” | PR · Jul 29, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| EDIT | EDIT-401 Phase 1/2 trial in heterozygous familial hypercholesterolemia | Q1 2027 (data update); 2027 (Part 1 topline) “The Company expects to report a data update in the first quarter of 2027. Editas plans to complete enrollment in Part 1, the dosefinding portion of the Phase 1/2 trial of EDIT-401,” | PR · Aug 5, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| GMAB | petosemtamab LiGeR-HN2 Phase 3 (second/third-line head and neck) · NCT06496178 | Q1 2027 “the second or third line study is anticipated to readout in the first quarter of 2027” | Call · Aug 6, 2026 | Est. Feb 14, 2027 quarter midpoint | Slipped |
| IBIO | IBIO-600 Phase 1 first interim data · NCT07487376 | Q1 2027 “The September 14 presentation specifies first interim Phase 1 data for IBIO-600 in Q1 2027.” | Deck · Sep 14, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| IMMX | NXC-201 NEXICART-2 1-year follow-up data · NCT06097832 | end of March 2027 “By end of March 2027, we expect to present 1-year follow-up data of enrolled patients, which we expect will drive BLA submission and commercial launch.” | PR · May 21, 2026 | Jan 12 - Feb 23 | Slipped |
| INMB | Ebstrocel FDA BLA in osteogenesis imperfecta | Q1 2027 “Ebstrocel™ Biologics License Application (BLA) submission to the FDA expected in Q1 2027.” | PR · Aug 6, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| LABT | Nu-3 Nu-3 Phase 2a in infected diabetic foot ulcers · NCT07565506 | Q1 2027 “Topline data from the Phase 2a study are expected in the first quarter of 2027.” | PR · Sep 24, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| LLY | retatrutide retatrutide Phase 3 program in obesity | Q1 2027 “Lilly plans to submit a Biologics License Application (BLA) for retatrutide to FDA in Q1 2027” | PR · Jul 23, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| LXRX | sotagliflozin SONATA-HCM Phase 3 in hypertrophic cardiomyopathy | Q1 2027 “Lexicon continues to expect topline results in the first quarter of 2027.” | PR · Aug 6, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| MDWD | EscharEx Phase 3 VALUE trial | End of Q1 2027 “The EscharEx Phase III VALUE trial is advancing across the U.S., Europe, and Israel, with the interim sample size reassessment and completion of enrollment expected by the end of t” | PR · Aug 13, 2026 | Jan 12 - Feb 23 | Pulled forward |
| MIRA | MIRA-55 MIRA-55 IND submission | Q1 2027 “Subject to successful completion of the remaining IND-enabling studies, applicable regulatory requirements and other development considerations, the Company is targeting submission” | Filing · Sep 1, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| MIRM | Volixibat Phase 2b VANTAGE study in primary biliary cholangitis | Q1 2027 “Completed enrollment in the volixibat VANTAGE Phase 2b study in cholestatic pruritus due to primary biliary cholangitis (PBC); topline results expected in Q1 2027.” | PR · Aug 5, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| NAMS | obicetrapib Phase 3 PREVAIL cardiovascular outcomes trial | Q1 2027 “PREVAIL interim analysis planned for 4Q2026 with result expected in 1Q2027” | PR · Aug 5, 2026 | Dec 13, 2026 - Jan 24, 2027 | On track |
| NKTR | rezpegaldesleukin REZOLVE-AD Phase 2b 52-week off-treatment data in atopic dermatitis | Q1 2027 “Likewise, in the first quarter of next year, we will have 52-week off-treatment data for our atopic dermatitis phase II-B study.” | Call · Aug 13, 2026 | Est. Feb 14, 2027 quarter midpoint | Slipped |
| OCGN | OCU400 liMeliGhT Phase 3 topline data | Q1 2027 “Top-line phase III data is expected in the first quarter of 2027, advancing OCU400 to a potential approval in the fourth quarter of 2027.” | Call · Aug 6, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| OLMA | palazestrant (OP-1250) OPERA-01 Phase 3 topline in ER+/HER2- metastatic breast cancer | Q1 2027 “Importantly, enrollment in our pivotal OPERA-01 Phase 3 trial is complete and we now expect to report top-line data in the first quarter of 2027.” | PR · Aug 10, 2026 | Dec 12, 2026 - Jan 23, 2027 | On track |
| ORKA | ORKA-002 ORCA-SURGE Phase 2 Week 16 data in moderate-to-severe plaque psoriasis | Q1 2027 “The Company now expects to report Week 16 data from ORCA-SURGE, a Phase 2 trial in moderate-to-severe PsO, in the first quarter of 2027.” | PR · Aug 10, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| PBLS | zolucatetide additional FAP data | Q1 2027 “Anticipate disclosing additional FAP data in the first quarter of 2027.” | PR · Aug 13, 2026 | Est. Feb 14, 2027 quarter midpoint | Slipped |
| PMN | PMN310 PRECISE-AD Phase 1b in early Alzheimer's disease | Q1 2027 “The trial remains blinded and ongoing with topline 12-month results expected in the first quarter of 2027.” | PR · Jul 28, 2026 | Jan 12 - Feb 23 | On track |
| PMVP | rezatapopt accelerated-approval NDA submission for platinum-resistant/refractory ovarian cancer | Q1 2027 “We anticipate submitting an NDA for accelerated approval of rezatapopt for platinum-resistant/refractory ovarian cancer in the first quarter of 2027.” | PR · Aug 14, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| QNCX | LAM-001 Phase 2 top line BOS data post lung transplant | Q1 2027 “We are pleased to have initiated the Phase 2b trial of LAM-001 for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) and look forward to re” | PR · Aug 14, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| SLDB | SGT-212 Phase 1b FALCON in Friedreich ataxia | Q1 2027 “Participant screening and enrollment remains ongoing, and the Company expects to report initial data in the first quarter of 2027, subject to participant enrollment.” | PR · Aug 6, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| SPRY | ARS-2 (neffy) Phase 2b in chronic spontaneous urticaria (CSU), interim | Q1 2027 “Interim data from Phase 2b trial in chronic spontaneous urticaria (CSU) expected in Q1 2027.” | PR · Aug 13, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| SRPT | ELEVIDYS (delandistrogene moxeparvovec-rokl) ENDEAVOR Cohort 8 - sirolimus-enhanced immunosuppression in non-ambulatory DMD; 12-week ALI/dystrophin data · NCT04626674 | Q1 2027 “When we looked at the timing of when we would have the 12-week data, it would be available in Q1 of next year. When we have the complete 12-week data from the 25 patients, that'll ” | Call · Aug 5, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| SVRA | molgramostim (MOLBREEVI, EU MAA) aPAP, EMA MAA under review | Q1 2027 “MOLBREEVI MAAs Under Review by the EMA and the U.K.'s MHRA; Decisions Expected in Q1 2027 and Q4 2026, respectively” | PR · Aug 12, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| TAK | zasocitinib (TAK-279) moderate-to-severe plaque psoriasis, FDA NDA under priority review | Q1 2027 “The Prescription Drug User Fee Act (PDUFA) target action date is in the first quarter of calendar year 2027” | PR · Sep 14, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| TRAX | ANB033 Phase 1b in celiac disease, Cohort 2 | Q1 2027 “Cohort 2 of this study is enrolling patients with disease across a wide range of histologic and symptom severity at baseline with the goal of generating deeper insights into timing” | PR · Aug 12, 2026 | Est. Feb 14, 2027 quarter midpoint | Slipped |
| TRDA | ENTR-601-44 ELEVATE-44-201 Phase 1/2 in Duchenne muscular dystrophy, Cohort 2 MAD (12 mg/kg) | Q1 2027 “Additional data from Cohort 2 MAD (12 mg/kg) is expected in the first quarter of 2027.” | PR · Aug 5, 2026 | Est. Feb 14, 2027 quarter midpoint | Slipped |
| TYRA | TYRA-300 (dabogratinib) BEACH301 Phase 2 safety-sentinel cohort in pediatric skeletal dysplasias | end of Q1 2027 “Initial Ph2 data from safety sentinel cohort (aggregate of ~25 children) in BEACH301, including new 5th dose level, now expected end of Q1 2027.” | PR · Aug 4, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| VERU | enobosarm PLATEAU Phase 3b trial of enobosarm: interim DXA body-composition analysis | Q1 2027 “Results of an interim analysis assessing lean body mass and fat mass as measured by DXA after patients have completed 32 weeks is expected in the first quarter of calendar year 202” | PR · Aug 10, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| VIR | elebsiran plus tobevibart Phase 3 ECLIPSE 2 trial of elebsiran plus tobevibart in chronic hepatitis delta | Q1 2027 “Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027.” | PR · Aug 5, 2026 | Jan 12 - Feb 23 | Slipped |
| VIR | elebsiran plus tobevibart Phase 3 ECLIPSE 3 trial of elebsiran plus tobevibart in chronic hepatitis delta | Q1 2027 “Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027.” | PR · Aug 5, 2026 | Jan 12 - Feb 23 | On track |
| VRAX | ViraxImmune ViraxImmune larger clinical validation analysis in long COVID and post-acute infection syndromes | Q1 2027 “Virax is preparing for its next major development milestone: a larger clinical validation analysis involving previously collected samples from 300 additional participants, with ana” | PR · Sep 24, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| VRCA | YCANTH (VP-102) Pivotal Phase 3 COVE-2 trial of YCANTH (VP-102) in common warts: topline data | Q1 2027 “We anticipate topline data from COVE-2 in the first quarter of 2027 and currently expect the remaining topline data for the program will be available by mid-2027.” | PR · Aug 27, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| VRDN | elegrobart (VRDN-003) BLA submission for elegrobart in thyroid eye disease | Q1 2027 “Viridian is on track to submit a Biologics License Application (BLA) to the FDA for elegrobart in Q1 2027.” | PR · Aug 6, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| XENE | azetukalner Phase 3 X-NOVA2 of azetukalner in major depressive disorder (MDD) | Q1 2027 “Enrollment in X-NOVA2 study in MDD completed with approximately 360 total patients; topline data readout expected Q1 2027.” | PR · Sep 17, 2026 | Est. Feb 14, 2027 quarter midpoint | — |
| HRMY | pitolisant GR NDA PDUFA | April 1, 2027 “NDA accepted by FDA in July; target PDUFA date of April 1, 2027” | PR · Aug 4, 2026 | — | — |
| INBX | ozekibart (INBRX-109) BLA in conventional chondrosarcoma | April 14, 2027 (PDUFA) “In June 2026, the U.S. Food and Drug Administration (FDA) accepted for filing the Company's biologics license application (BLA) for the potential approval of ozekibart in conventio” | PR · Aug 6, 2026 | — | — |
| PHVS | deucrictibant IR NDA for on-demand treatment of HAE attacks, PDUFA target action date · NCT06343779 | April 23, 2027 “The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 23, 2027.” | PR · Jul 6, 2026 | — | — |
| ORGO | ReNu (proposed Amnuvx) BLA PDUFA for symptomatic knee osteoarthritis | April 24, 2027 “The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2027.” | PR · Jul 6, 2026 | — | — |
| IMNM | varegacestat (AL102) Phase 3 RINGSIDE in desmoid tumors | April 28, 2027 (PDUFA) “In July 2026, the U.S. FDA accepted Immunome's NDA for varegacestat for the treatment of adults with desmoid tumors and assigned a PDUFA target action date of April 28, 2027.” | PR · Aug 11, 2026 | — | — |
| ABSI | ABS-201 HEADLINE Phase 1/2a in pattern hair loss, full proof-of-concept · NCT07317544 | early 2027 “Absci anticipates reporting interim proof-of-concept data in the second half of 2026 and full proof-of-concept data in early 2027.” | Filing · Aug 11, 2026 | Est. Mar 1, 2027 guidance midpoint | Slipped |
| AKTX | AKTX-101 IND or CTA submission | late 2026 or early 2027 “This collaboration supports Akari's goal of submitting an IND or CTA for AKTX-101 in late 2026 or early 2027” | Source · Mar 13, 2026 | Est. Dec 30, 2026 guidance midpoint | — |
| ALVO | AVT16 approval decision | early 2027 “I do think with the submission, we are expecting an approval decision in early 2027.” | Call · Aug 20, 2026 | Est. Mar 1, 2027 guidance midpoint | — |
| COCP | CDI-988 Phase 1b norovirus challenge study (prevention + treatment) · NCT07198139 | late 2026 or early 2027 “We look forward to reporting preliminary results near the end of 2026 or early 2027 and to advancing CDI-988 as a potential first-in-class oral antiviral for norovirus.” | PR · Sep 9, 2026 | Nov 12 - Dec 24 | On track |
| COYA | COYA 302 ALSTARS Phase 2/3 trial (topline) · NCT07161999 | early Q2 2027 “Based on current enrollment trends, Coya anticipates completing full enrollment of 120 participants in sufficient time to permit reporting topline data in early Q2 of 2027.” | PR · Sep 15, 2026 | — | — |
| CRVS | soquelitinib Angel Pharmaceuticals Phase 2 trial in asthma (China) - initiation guided | early 2027 “Angel Pharma anticipates that it will initiate the Phase 2 asthma trial in early 2027.” | PR · Aug 6, 2026 | Est. Mar 1, 2027 guidance midpoint | Slipped |
| HRMY | BP-205 Phase 1b (sleep-deprived healthy volunteers) | early 2027 “US IND open; initiate Phase 1b study in sleep-deprived healthy volunteers in Q3; data expected in early 2027” | PR · Aug 4, 2026 | Est. Mar 1, 2027 guidance midpoint | Slipped |
| HROW | TRIESENCE Phase 3 (cataract surgery) | early 2027 “The Company's Phase 3 trial evaluating TRIESENCE for the treatment of ocular inflammation and pain following cataract surgery is on track to fully enroll in 2026, with topline data” | PR · Aug 10, 2026 | Est. Mar 1, 2027 guidance midpoint | — |
| IDYA | IDE034 Phase 1 dose escalation initial data | end-2026 / early 2027 “IDEAYA plans to provide initial clinical data from its ongoing Phase 1 dose escalation trial by the end of 2026 or early 2027, which is expected to include preliminary safety and e” | PR · Aug 4, 2026 | Est. Feb 14, 2027 guidance midpoint | — |
| IMCR | IMC-M113V HIV results | early 2027 “Analysis of the new data is ongoing with results planned to be shared early next year.” | Call · Aug 6, 2026 | Est. Mar 1, 2027 guidance midpoint | — |
| MAZE | MZE829 HORIZON Phase 2 in APOL1-mediated kidney disease | late 2026 / early 2027 “Maze continues to enroll the HORIZON trial, and expects to announce updated data in late 2026 or early 2027 on three 10-15 patient cohorts” | PR · Aug 11, 2026 | Now - Nov 24, 2026 | On track |
| OPK | MDX2301 Phase 1 COVID-19 prevention early data | late 2026 or early 2027 “Initiated MDX2301 Phase 1 clinical trial for the prevention of COVID-19, with plans to complete enrollment in the third quarter 2026 and early data to be presented in late 2026 or ” | PR · Jul 27, 2026 | Est. Dec 30, 2026 guidance midpoint | — |
| SEPN | SEP-479 Phase 1 single/multiple-ascending dose in healthy volunteers | late 2026 or early 2027 “SEP-479 is currently being evaluated in an ongoing Phase 1 single-ascending dose and multiple-ascending dose study in healthy volunteers, with data expected in late 2026 or early 2” | PR · Jun 8, 2026 | Est. Dec 30, 2026 guidance midpoint | — |
| TGTX | BRIUMVI (ublituximab), subcutaneous quarterly regimen Phase 3 subcutaneous BRIUMVI in relapsing multiple sclerosis | year-end 2026 or early 2027 “Top-line Phase 3 data is expected year-end 2026 or early 2027” | PR · Aug 3, 2026 | Dec 12, 2026 - Jan 23, 2027 | On track |
| VRTX | inaxaplin Phase 2/3 AMPLITUDE trial of inaxaplin in APOL1-mediated kidney disease: pre-planned interim analysis | early 2027 “Vertex is on track to share data from the pre-planned interim analysis (IA) of AMPLITUDE in early 2027 once the IA cohort reaches 48 weeks of treatment.” | PR · Sep 22, 2026 | Est. Mar 1, 2027 guidance midpoint | — |
| AXSM | AXS-12 NDA for cataplexy in narcolepsy, PDUFA target action | May 1, 2027 “Axsome's NDA submission for AXS-12 for the treatment of cataplexy in narcolepsy was accepted by the FDA and assigned a PDUFA target action date of May 1, 2027.” | Filing · Aug 10, 2026 | — | — |
| BBIO | encaleret NDA PDUFA | May 8, 2027 “PDUFA date set for May 8, 2027 with Priority Review; MAA submitted to EMA” | PR · Aug 10, 2026 | — | — |
| BMY | mezigdomide NDA PDUFA in relapsed/refractory multiple myeloma | May 13, 2027 “The FDA has granted a Prescription Drug User Fee Act (PDUFA) date of May 13, 2027 for this indication.” | PR · Jul 13, 2026 | — | — |
| ZBIO | obexelimab BLA for obexelimab in IgG4-related disease: PDUFA target action date | 2027-05-27 “In August 2026, the FDA accepted the Company’s Biologics License Application (BLA) for obexelimab for the treatment of IgG4-RD. The BLA has a Prescription Drug User Fee Act (PDUFA)” | PR · Sep 8, 2026 | — | Slipped |
| ACHV | cytisinicline potential FDA approval for smoking cessation | H1 2027 “Achieve intends to resubmit its NDA in the fourth quarter of 2026, naming Adare as its primary manufacturing partner, with potential FDA approval in the first half of 2027, followe” | PR · Jun 22, 2026 | Dec 27, 2026 - Feb 7, 2027 | Slipped |
| ACRV | CDK11 inhibitor IND filing to FDA for development candidate | H1 2027 “Submit IND filing to the FDA for CDK11 inhibitor development candidate in first half of 2027” | PR · Aug 12, 2026 | Est. Apr 1, 2027 half midpoint | — |
| ADAG | muzastotug (ADG126) randomized Phase 2 in MSS CRC, results | 1H 2027 “Enrollment into the randomized Phase 2 trial is well on-track, and results are expected in 1H 2027.” | PR · Aug 12, 2026 | Est. Apr 1, 2027 half midpoint | — |
| ADCT | ZYNLONTA (loncastuximab tesirine-lpyl) investigator-initiated Phase 2 in combination with rituximab in r/r follicular lymphoma, updated data presentation | Q2 2027 “The Company also anticipates presentation of updated FL data in Q2 2027.” | PR · Aug 13, 2026 | Est. May 16, 2027 quarter midpoint | Slipped |
| ANL | AN0025 ARTEMIS Phase II in rectal cancer | 1H 2027 “The futility analysis of this Phase II study was successfully passed in March 2026, and the topline results are expected in the first half of 2027.” | PR · Aug 14, 2026 | Est. Apr 1, 2027 half midpoint | — |
| ANL | AN9025 Phase Ia QD/QW in RAS-mutant solid tumors | 1H 2027 “The Company remains on track to share initial Phase Ia dose escalation data in the first half of 2027 from the QD arm, with a potential early look at the QW arm.” | PR · Aug 14, 2026 | Est. Apr 1, 2027 half midpoint | — |
| ANRO | ALTO-300 Phase 2b in major depressive disorder | 1H 2027 “Topline data remain expected in 1H 2027 for the ALTO-300 Phase 2b MDD trial and mid-2027 for the ALTO-100 Phase 2b BPD trial.” | PR · Aug 12, 2026 | Jan 12 - Feb 23 | On track |
| ARGX | efgartigimod ADVANCE-NEXT registrational in primary ITP | 1H 2027 “Topline results from registrational ADVANCE-NEXT study (primary ITP) expected in first half of 2027” | PR · Jul 23, 2026 | Est. Apr 1, 2027 half midpoint | Slipped |
| ARVN | ARV-027 Phase 1 in healthy volunteers (SBMA/Kennedy’s disease program) | 1H 2027 “Continue enrollment in the multiple dose cohort of the Phase 1 clinical trial in healthy volunteers and share initial data evaluating androgen receptor (AR)-degradation in muscle (” | PR · Aug 4, 2026 | Est. Apr 1, 2027 half midpoint | — |
| AVIR | bemnifosbuvir + ruzasvir (BEM/RZR) NDA submission to FDA | Q2 2027 “Atea anticipates submitting a new drug application (NDA) to the US Food & Drug Administration (FDA) in the second quarter of 2027.” | PR · Aug 12, 2026 | Est. May 16, 2027 quarter midpoint | Slipped |
| AVTX | AVTX-010 IND application submission | H1 2027 “The Company expects to submit an Investigational New Drug (IND) application in the first half of 2027.” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| AVTX | abdakibart Registrational Phase 3 program in hidradenitis suppurativa, initiation | H1 2027 “Avalo plans to initiate a registrational Phase 3 program evaluating abdakibart in HS in the first half of 2027.” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| BMEA | icovamenib COVALENT-212 Phase II 26-week primary endpoint topline · NCT07502508 | Q2 2027 “COVALENT-212 Phase II enrollment T2D patients who are not achieving glycemic targets despite GLP-1 based therapy is still ongoing, with topline 26-week primary endpoint data antici” | PR · Aug 24, 2026 | Est. May 16, 2027 quarter midpoint | Slipped |
| CBIO | CR-001 ASCEND dose expansion: CR-001 in combination with standard of care chemotherapy | mid-2027 (Q2/Q3) “Initial data of CR-001 in combination with various standard of care chemotherapy regimens in first-line and previously treated patients by mid-2027 (Q2/Q3) utilizing the dose expan” | PR · Jul 30, 2026 | Est. May 16, 2027 quarter midpoint | Slipped |
| CBIO | CR-001 China Phase 2 trial of CR-001 in combination with sac-TMT in NSCLC | mid-2027 (Q2/Q3) “Initial data from the Phase 2 trial in China of CR-001 in combination with sac-TMT in mid-2027 (Q2/Q3).” | PR · Jul 30, 2026 | Est. May 16, 2027 quarter midpoint | — |
| CLYM | CLYM116 NAVIGATE-2 Phase 2 in IgA nephropathy (initial data) | H1 2027 “Initial data from NAVIGATE-2 Phase 2 anticipated in the first half of 2027” | PR · Sep 3, 2026 | Est. Apr 1, 2027 half midpoint | Slipped |
| CTMX | CX-801 Phase 1 trial in combination with KEYTRUDA in advanced melanoma | 1H 2027 “Initial clinical data for CX-801 in combination with KEYTRUDA® in advanced melanoma is expected in the first half of 2027.” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| DFTX | DT120 Panorama Phase 3 in generalized anxiety disorder | 1H 2027 “Pre-NDA meeting scheduled in 4Q 2026; NDA filing anticipated in 1H 2027.” | PR · Sep 14, 2026 | Est. Apr 1, 2027 half midpoint | — |
| DNLI | DNL151 Phase 2a BEACON study in LRRK2-variant Parkinson's disease | 1H 2027 “Data from BEACON are expected in the first half of 2027.” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| DNLI | DNL628 Phase 1b study in Alzheimer's disease | 1H 2027 “Initial clinical biomarker data from the ongoing Phase 1b study of DNL628 in participants with Alzheimer's disease are expected in the first half of 2027.” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| ELUT | NXT-41x | 1H 2027 “The Company continues to expect FDA clearance for NXT-41 in the fourth quarter of 2026 and for NXT-41x in the first half of 2027.” | PR · Aug 13, 2026 | Est. Apr 1, 2027 half midpoint | — |
| ENLV | Allocetra Phase 2b in knee osteoarthritis | by the end of Q2 2027 “The Company previously announced the dosing of the first patient in the U.S. clinical site and believes that top-line data from this clinical trial will be available by the end of ” | PR · Jul 13, 2026 | Est. May 16, 2027 quarter midpoint | — |
| ERAS | ERAS-0015 Phase 1 monotherapy expansion | 1H 2027 “Phase 1 monotherapy expansion data expected in the first half of 2027” | Filing · Aug 11, 2026 | Est. Apr 1, 2027 half midpoint | — |
| ERAS | ERAS-0015 Phase 1 combination dose escalation (incl. panitumumab) | 1H 2027 “Phase 1 combination dose escalation data, including panitumumab combination, expected in the first half of 2027” | Filing · Aug 11, 2026 | Est. Apr 1, 2027 half midpoint | — |
| ETON | KHINDIVI | H1 2027 “The new formulation of KHINDIVI successfully demonstrated bioequivalence to ALKINDI SPRINKLE, paving the way for a potential first half of 2027 approval.” | PR · Aug 13, 2026 | Est. Apr 1, 2027 half midpoint | — |
| ETRA | ELA822 Phase 1 in healthy volunteers | 1H 2027 “In August 2026, we obtained regulatory clearance and initiated a Phase 1 clinical trial of ELA822 in healthy volunteers in Europe, with data in expected in the first half of 2027.” | Filing · Aug 28, 2026 | Est. Apr 1, 2027 half midpoint | — |
| FDMT | 4D-150 4FRONT-1 Phase 3 in wet AMD | Q2 2027 “Enrollment completed in February 2026 and randomization completed (N=523) in March 2026; topline data expected in Q2 2027” | PR · Aug 13, 2026 | Est. May 16, 2027 quarter midpoint | Slipped |
| GNPX | REQORSA + Tecentriq Acclaim-3 Phase 2 expansion (interim analysis) | 1H 2027 “The Company expects to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study by the end of 2026 and expects the interim an” | Filing · Aug 14, 2026 | Est. Apr 1, 2027 half midpoint | — |
| GPCR | ACCG-2671 Phase 1/2a MAD | 1H 2027 “First participants dosed with ACCG-2671 in the 12-week MAD portion of the Phase 1/2a clinical trial; topline data expected in 1H 2027” | PR · Sep 8, 2026 | Est. Apr 1, 2027 half midpoint | — |
| HRMY | EPX-100 (clemizole) LIGHTHOUSE / ARGUS Phase 3 topline | 1H 2027 “Topline data expected in 1H 2027 and anticipated PDUFA dates in 2028” | PR · Aug 4, 2026 | Dec 13, 2026 - Jan 24, 2027 | On track |
| HURA | IFx-2.0 IR study + Keytruda (deep-seated MCC) | 1H 2027 “1H2027: Expect preliminary results from IR study IFX-2.0 with Keytruda® for deep seated MCC” | PR · Aug 14, 2026 | Est. Apr 1, 2027 half midpoint | — |
| HURA | TBS-2025 Phase 1b/2 VISTA (mutNPM1 r/r AML) | 1H 2027 “1H 2027: Expect preliminary safety and response data for VISTA in mutated NMP1 r/r AML” | PR · Aug 14, 2026 | Est. Apr 1, 2027 half midpoint | — |
| IMTX | anzu-cel (anzutresgene autoleucel, IMA203) Phase 3 SUPRAME in advanced melanoma | H1 2027 “SUPRAME topline data disclosure for the final PFS analysis expected in H1 2027, followed by BLA submission in 2027” | PR · Aug 18, 2026 | Est. Apr 1, 2027 half midpoint | — |
| IRD | OPGx-BEST1 Phase 1/2 BIRD-1 in BEST1-related retinal diseases (Cohort 2) | Q2 2027 “with dosing expected to be complete in the fourth quarter of 2026 and topline three-month data expected to be available in the second quarter of 2027.” | Filing · Sep 9, 2026 | Est. May 16, 2027 quarter midpoint | — |
| JANX | JANX007 Phase 1b in mCRPC | H1 2027 “Additional clinical data for JANX007 expected to be announced at a future medical congress in the first half of 2027.” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| JAZZ | dordaviprone (Modeyso) Phase 3 ACTION | 1H27 “Anticipate the OS interim analysis for the event-driven Phase 3 ACTION trial in 1H27, based on current pace of event accrual.” | PR · Aug 3, 2026 | Est. Apr 1, 2027 guidance midpoint | — |
| KARD | danicamtiv KINSHIP-DCM Phase 2b/3 adaptive trial in genetic dilated cardiomyopathy | H1 2027 “Danicamtiv KINSHIP-DCM Phase 3 Cohort 1 enrollment now underway; Phase 2b topline data expected 1H 2027” | PR · Aug 11, 2026 | Est. Apr 1, 2027 half midpoint | — |
| KLRS | TH103 TH103 Phase 1b/2 in neovascular AMD | H1 2027 “Preliminary data from the Phase 1b/2 study is expected in the first half of 2027.” | PR · Aug 11, 2026 | Est. Apr 1, 2027 half midpoint | — |
| KOD | KSI-101 (PEAK/PINNACLE Pivotal Analysis 2) PEAK and PINNACLE Pivotal Analysis 2 in Macular Edema Secondary to Inflammation · NCT06990399 | Q2 2027 “Completion of enrollment in the second pivotal cohort evaluating 600 subjects across PEAK and PINNACLE supporting Pivotal Analysis 2 is expected in the fourth quarter of 2026, with” | PR · Aug 13, 2026 | Est. May 16, 2027 quarter midpoint | — |
| KROS | rinvatercept rinvatercept Phase 2 in Duchenne muscular dystrophy | H1 2027 “We look forward to the progression of the Phase 2 clinical trial, and continue to expect to present initial data in the first half of 2027.” | PR · Aug 3, 2026 | Est. Apr 1, 2027 half midpoint | — |
| LBRX | LB-102 NOVA-2 Phase 3 in schizophrenia | H1 2027 “Based on the pace of enrollment since initiating NOVA-2, we now expect to report topline results in the first half of 2027, ahead of our prior guidance of the second half of 2027, ” | PR · Jul 22, 2026 | Est. Apr 1, 2027 half midpoint | — |
| MDWD | EscharEx Phase 3 VALUE trial in venous leg ulcers | Q2 2027 “Our plan is to have the interim assessment by the end of Q1. If everything goes well, it takes another quarter or so to get the top-line data. After the top-line data, it is anothe” | Call · Aug 13, 2026 | Jan 12 - Feb 23 | Slipped |
| MGNX | Lorigerlimab Phase 2 LINNET study in advanced gynecologic cancers | H1 2027 “The Company is enrolling 20 additional patients with clear cell gynecologic cancer (CCGC) at a dose of 3 mg/kg Q3W and anticipates reporting updated study results in the first half” | PR · Aug 13, 2026 | Est. Apr 1, 2027 half midpoint | — |
| MIRM | Volixibat Volixibat NDA in cholestatic pruritus due to PSC | H1 2027 “Participated in pre-NDA meeting with U.S. FDA for volixibat in cholestatic pruritus due to PSC; planning additional discussions with the FDA before potential NDA submission, now ta” | PR · Aug 5, 2026 | Est. Apr 1, 2027 half midpoint | Slipped |
| MIST | Etripamil (CARDAMYST) Etripamil marketing authorization application in PSVT (EMA) | H1 2027 “Regulatory review of the marketing authorization application for etripamil for PSVT in Europe remains on track for a decision from the European Medicines Agency (EMA) in the first ” | PR · Aug 12, 2026 | Est. Apr 1, 2027 half midpoint | — |
| MLTX | Sonelokimab Phase 3 IZAR-1 trial in psoriatic arthritis (full Week 52 readout) | H1 2027 “The IZAR-1 trial remains blinded and will continue until Week 52 with MoonLake expecting the full readout in H1 2027 whereas the IZAR-2 trial (a trial in TNF-refractory patients) i” | PR · Aug 10, 2026 | Est. Apr 1, 2027 half midpoint | Slipped |
| NVO | CagriSema REDEFINE 11 Phase 3 data in obesity | 1H 2027 “The REDEFINE 11 phase 3 trial exploring CagriSema 2.4/2.4 mg full weight-loss potential in obesity is expected to report data during the first half of 2027, while initiation of the” | PR · Feb 23, 2026 | Est. Apr 1, 2027 half midpoint | Slipped |
| OBIO | AVIM Therapy BACKBEAT pivotal trial primary endpoint data | Q2 2027 “We remain on track to reach or exceed our target of 284 evaluable randomized patients in the BACKBEAT Trial by the end of the third quarter of 2026 and maintain our objective to pr” | PR · Aug 10, 2026 | Est. May 16, 2027 quarter midpoint | — |
| OBX | amsoki-cel (OBX-115) Agni-01 Phase 1 NSCLC data · NCT06060613 | 1H 2027 “These include Phase 1 data from the ongoing non-small cell lung cancer (NSCLC) trial expected in the first half of 2027, and topline data from the melanoma registration-enabling tr” | PR · Aug 3, 2026 | Est. Apr 1, 2027 half midpoint | — |
| OCGN | OCU410ST GARDian3 Phase 2/3 topline data | Q2 2027 “We expect the interim outcome decision for the first 50% of subjects at eight months in the third quarter of 2026, and top-line phase II/III data in the second quarter of 2027, wit” | Call · Aug 6, 2026 | Nov 9 - Dec 21 | Guide later than CT.gov |
| OKUR | OKI-345 IND submission for breast cancer | 1H 2027 “OnKure plans to submit an IND application to the FDA for OKI-345 in the first half of 2027.” | PR · Aug 4, 2026 | Est. Apr 1, 2027 half midpoint | — |
| OKUR | OKI-355 IND submission for vascular anomalies | 1H 2027 “OnKure plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for OKI-355 in the first half of 2027.” | PR · Aug 4, 2026 | Est. Apr 1, 2027 half midpoint | — |
| OKYO | urcosimod Phase 2b/3 topline data in neuropathic corneal pain | 1H 2027 “Topline data expected 1H2027.” | Deck · Aug 1, 2026 | Est. Apr 1, 2027 half midpoint | — |
| OPK | MDX2001 / MDX2004 Phase 1 initial safety, tolerability, PK and immune data | 1H 2027 “MDX2001, a tetraspecific T cell engager directed to solid tumors that express Trop2 and c-Met, is proceeding with Phase 1 enrollment as planned. MDX2004 a trispecific immune rejuve” | PR · Jul 27, 2026 | Est. Apr 1, 2027 half midpoint | — |
| PBLS | zolucatetide ACP clinical data from additional patients | H1 2027 “Expect to share clinical data from additional patients in the first half of 2027 for ACP” | PR · Aug 13, 2026 | Est. Apr 1, 2027 half midpoint | Slipped |
| PCVX | VAX-31 OPUS-2 and OPUS-3 adult Phase 3 of VAX-31 | H1 2027 “OPUS-2 and OPUS-3 Phase 3 Results Expected in First Half of 2027” | PR · Aug 5, 2026 | Est. Apr 1, 2027 half midpoint | Slipped |
| PEPG | PGN-EDODM1 end of Phase 2 meeting with regulators to discuss registrational program | following 12.5 mg/kg cohort results, expected H1 2027 “Pending results from Cohorts 2 and 3, PepGen plans to engage with regulators in an end of Phase 2 (EOP2) meeting to discuss plans for the registrational program.” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | Slipped |
| PEPG | PGN-EDODM1 FREEDOM2-DM1 Phase 2 in DM1 (12.5 mg/kg cohort) | H1 2027 “– Results from 12.5 mg/kg FREEDOM2-DM1 cohort expected in 1H 2027 –” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| PHVS | deucrictibant XR CHAPTER-3 pivotal Phase 3, marketing authorization applications · NCT06669754 | starting H1 2027 “Data from the CHAPTER-3 study will serve as the basis for marketing authorization applications, which are planned to be submitted starting in the first half of 2027.” | PR · Sep 8, 2026 | Est. Apr 1, 2027 half midpoint | — |
| PRME | PM359 BLA submission for chronic granulomatous disease | H1 2027 “Continued regulatory engagement with the FDA toward a BLA submission for PM359 in the first half of 2027.” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| PROK | rilparencel PROACT 1 pivotal eGFR slope topline readout | Q2 2027 “This update marks an important milestone for ProKidney as we have completed enrollment for the PROACT 1 accelerated approval analysis, positioning us for our pivotal eGFR slope top” | PR · Aug 10, 2026 | Est. May 16, 2027 quarter midpoint | — |
| QNRX | QRX003 CL-QRX003-004 (20 participants) | Q2 2027 “Quoin expects to complete recruitment of all 20 participants in CL-QRX003-004 by the end of 2026 and report topline data in the second quarter of 2027.” | Filing · Aug 28, 2026 | Est. May 16, 2027 quarter midpoint | — |
| RARE | DTX301 Enh3ance study second primary endpoint (treatment burden) | H1 2027 “Data from the second primary endpoint, which evaluates reduction in treatment burden, including use of ammonia scavengers and dietary management, are expected in the first half of ” | PR · Aug 4, 2026 | Est. Apr 1, 2027 half midpoint | — |
| RNAC | Descartes-08 mRNA in vivo CAR-T (WestGene LNP) Clinical trial in myasthenia gravis (WestGene LNP platform) | 1H 2027 “Clinical trial expected to initiate in 2H 2026 using mRNA payload from Descartes-08 combined with WestGene’s LNP platform in patients with MG; Clinical data expected in 1H 2027.” | PR · Jun 9, 2026 | Est. Apr 1, 2027 half midpoint | — |
| SCTX | STX-1150 Phase 1 single-ascending dose (SAD) · NCT07428473 | H1 2027 “Scribe anticipates reporting initial clinical data, including safety, tolerability, and LDL-C lowering activity, from the single ascending dose (SAD) portion of the STX-1150 Phase ” | PR · Sep 2, 2026 | Est. Apr 1, 2027 half midpoint | — |
| SER | SER-252 Phase 1b single-ascending dose | H1 2027 “we expect top-line data from the single-ascending-dose arm in the first half of 2027.” | PR · Aug 13, 2026 | Est. Apr 1, 2027 half midpoint | — |
| SLDB | SGT-501 Phase 1b ARTEMIS in catecholaminergic polymorphic ventricular tachycardia (CPVT) | H1 2027 “Solid expects to dose the first participant in the second half of 2026, with initial safety data anticipated in the first half of 2027, subject to participant enrollment.” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| SMMT | ivonescimab (HARMONi-3, non-squamous PFS) HARMONi-3 Phase 3 in first-line non-squamous NSCLC (primary PFS analysis) · NCT05899608 | H1 2027 “For the non-squamous cohort, the number of events needed to conduct the PFS analysis is expected to be reached in the first half of 2027.” | PR · Jul 23, 2026 | Est. Apr 1, 2027 half midpoint | — |
| SMMT | ivonescimab (HARMONi-3, squamous OS interim) HARMONi-3 Phase 3 in first-line squamous NSCLC (independent interim OS analysis) · NCT05899608 | H1 2027 “An interim analysis for overall survival independent of PFS is planned for the first half of 2027.” | PR · Jul 23, 2026 | Est. Apr 1, 2027 half midpoint | — |
| SPTX | SPT-300 (GlyphAllo, BUOY-1) BUOY-1 Phase 2b in major depressive disorder (MDD) | H1 2027 “Topline data from the BUOY-1 trial are expected in the first half of 2027.” | PR · Aug 3, 2026 | Est. Apr 1, 2027 half midpoint | — |
| TARS | TP-04 Phase 2 KORE in ocular rosacea | 1H 2027 “The Phase 2 KORE trial evaluating TP-04, a lotilaner-based sterile ophthalmic gel formulation for the potential treatment of ocular rosacea, continues to progress with topline data” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| TARS | TP-05 Phase 2 Calliope in Lyme disease prophylaxis | 1H 2027 “Completed enrollment for Calliope, a Phase 2 trial evaluating TP-05, a novel investigational lotilaner-based oral prophylactic designed to kill ticks carrying Lyme disease before p” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| TPST | TPST-4003 investigator-initiated in vivo CAR-T study in myasthenia gravis and multiple sclerosis (first patient dosing Q4 2026) | 1H 2027 “Executed a development collaboration with Senlang Biotechnology to advance certain in vivo CAR-T product candidates, including TPST-4003, a CD7-targeted next-generation in vivo CAR” | PR · Aug 13, 2026 | Est. Apr 1, 2027 half midpoint | — |
| TRDA | ENTR-601-45 ELEVATE-45-201 Phase 1/2 in Duchenne muscular dystrophy, Cohort 2 MAD (10 mg/kg) | 1H 2027 “data from the Cohort 2 MAD (10 mg/kg) in the first half of 2027” | PR · Aug 5, 2026 | Est. Apr 1, 2027 half midpoint | Slipped |
| TSHA | TSHA-102 REVEAL/ASPIRE pivotal studies in Rett syndrome (6-month interim analysis; BLA submission pathway feedback) | 1H 2027 “Completed dosing in the REVEAL pivotal (N=17) and ASPIRE (N=4) trials evaluating TSHA-102 for Rett syndrome; expect to report topline data from 6-month interim analysis and FDA fee” | PR · Aug 11, 2026 | Est. Apr 1, 2027 half midpoint | — |
| VOR | telitacicept Phase 3 UPSTREAM MG trial of telitacicept in generalized myasthenia gravis | 1H 2027 “Topline data anticipated in 1H 2027.” | PR · Aug 11, 2026 | Est. Apr 1, 2027 half midpoint | — |
| VTRS | cenerimod Phase 3 OPUS-1 trial of cenerimod in systemic lupus erythematosus | 1H 2027 “For Cenerimod, we continue to expect results from both phase III SLE studies, OPUS-1 and OPUS-2, in the first half of 2027.” | Call · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| VTRS | cenerimod Phase 3 OPUS-2 trial of cenerimod in systemic lupus erythematosus | 1H 2027 “For Cenerimod, we continue to expect results from both phase III SLE studies, OPUS-1 and OPUS-2, in the first half of 2027.” | Call · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| VTRS | selatogrel Phase 3 SOS-AMI trial of selatogrel in acute myocardial infarction: data readout | 1H 2027 “We continue to expect a data readout in the first half of 2027.” | Call · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| WHWK | HWK-007 Phase 1 trial of HWK-007: initial results | 1H 2027 “HWK-007 and HWK-016 – ongoing recruitment into Phase 1 trials, with initial results expected in 1H 2027.” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| WHWK | HWK-016 Phase 1 trial of HWK-016: initial results | 1H 2027 “HWK-007 and HWK-016 – ongoing recruitment into Phase 1 trials, with initial results expected in 1H 2027.” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| XNCR | XmAb412 Phase 1 first-in-human study of XmAb412: healthy-participant data | 1H 2027 “And we recently started the Phase 1 study of XmAb412, our first XenLock™ bispecific antibody, and plan to have healthy participant data in the first half of 2027.” | PR · Aug 5, 2026 | Est. Apr 1, 2027 half midpoint | — |
| ZLAB | ZL-1503 Phase 1/1b study of ZL-1503: MAD initial clinical data | 1H 2027 “Initial clinical data from the MAD portion expected in the first half of 2027.” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | Slipped |
| ZLAB | ZL-6201 Phase 1a/b study of ZL-6201 in sarcoma and selected tumors: dose-escalation topline results | 1H 2027 “Provide topline results from the dose-escalation portion of the global Phase 1a/b study evaluating ZL-6201 in patients with sarcoma and selected tumors in the first half of 2027.” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | — |
| ZNTL | azenosertib registration-intended DENALI Phase 2 of azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer | H1 2027 “We expect to provide the topline readout of DENALI Part 2 in 1H 2027.” | PR · Aug 6, 2026 | Est. Apr 1, 2027 half midpoint | Slipped |
| ZURA | tibulizumab Phase 2 TibuSURE trial of tibulizumab in systemic sclerosis: topline data | 1H 2027 “Topline data are anticipated in the first half of 2027.” | PR · Aug 11, 2026 | Est. Apr 1, 2027 half midpoint | Slipped |
| ABVX | obefazimod ENHANCE-CD Phase 2b induction trial in Crohn's disease, topline · NCT06456593 | mid-year 2027 “Topline results of Phase 2b induction trial for Crohn's disease expected mid-year 2027” | PR · Jun 1, 2026 | Jan 12 - Feb 23 | Slipped |
| ALLO | cema-cel ALPHA3 study, interim event-free survival analysis program update · NCT06500273 | mid-2027 “The next program update tied to the interim event-free survival (EFS) analysis is expected in mid-2027.” | PR · Aug 12, 2026 | Est. Jul 16, 2027 guidance midpoint | — |
| ALXO | evorpacept ASPEN-09-Breast Phase 2 in HER2-positive metastatic breast cancer | mid-2027 “Enrollment in our ASPEN-09-Breast trial remains on track as we work toward a topline data readout from 80 patients in mid-2027, while ALX2004 continues to advance through dose esca” | PR · Aug 6, 2026 | Est. Jul 16, 2027 guidance midpoint | — |
| ANRO | ALTO-100 Phase 2b in bipolar depression | mid-2027 “Topline data remain expected in 1H 2027 for the ALTO-300 Phase 2b MDD trial and mid-2027 for the ALTO-100 Phase 2b BPD trial.” | PR · Aug 12, 2026 | Est. Jul 16, 2027 guidance midpoint | — |
| ARWR | zodasiran YOSEMITE Phase 3 in HoFH · NCT07037771 | mid-2027 “Arrowhead anticipates that YOSEMITE will be completed in mid-2027 and, pending successful clinical results, intends to seek regulatory approval in multiple geographies thereafter.” | PR · Jul 27, 2026 | Est. Jul 16, 2027 guidance midpoint | — |
| BBOT | BBO-11818 and BBO-10203 Combination cohort data in colorectal cancer and pancreatic ductal adenocarcinoma | mid-2027 “Data from BBO-11818 and BBO-10203 internal and standard-of-care combination cohorts in colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) expected in mid-2027.” | PR · Sep 8, 2026 | Est. Jul 16, 2027 guidance midpoint | Slipped |
| BBOT | BBO-8520 Expanded BBO-8520 plus pembrolizumab dataset in 2L+ KRAS G12C inhibitor-experienced NSCLC | mid-2027 “Expanded BBO-8520 plus pembrolizumab dataset in 2L+ KRAS G12C inhibitor-experienced NSCLC expected in mid-2027.” | PR · Sep 8, 2026 | Est. Jul 16, 2027 guidance midpoint | — |
| BCAX | ficerafusp alfa Interim analysis of FORTIFI-HN01 pivotal trial in 1L HPV-negative recurrent/metastatic HNSCC | mid-2027 “with topline data from an interim analysis of the FORTIFI-HN01 pivotal trial expected in mid-2027.” | PR · Aug 11, 2026 | Est. Jul 16, 2027 guidance midpoint | — |
| BIOA | BGE-102 Phase 1b/2a QUELL-DME data in diabetic macular edema | mid-2027 “QUELL-DME, Phase 1b/2a proof-of-concept trial of BGE-102 in diabetic macular edema, planned to initiate in mid-2026, with data anticipated in mid-2027” | Filing · Aug 5, 2026 | Est. Jul 16, 2027 guidance midpoint | Slipped |
| BNTC | BB-301 Pivotal trial initiation | mid-2027 “Benitec anticipates initiating the BB-301 pivotal trial in mid-2027.” | PR · Sep 14, 2026 | Est. Jul 16, 2027 guidance midpoint | Slipped |
| CABA | rese-cel Registrational RESET-Myositis clinical data | mid-2027 “Registrational RESET-Myositis clinical data on track to be reported in mid-2027 to support 2H27 BLA submission for rese-cel” | PR · Aug 13, 2026 | Est. Jul 16, 2027 guidance midpoint | — |
| CCCC | cemsidomide Phase 1b trial in combination with elranatamab (all cohorts data) | mid-2027 “C4T expects to provide an update on the dose escalation progress in the second half of 2026 with data from all cohorts expected in mid-2027.” | PR · Aug 11, 2026 | Est. Jul 16, 2027 guidance midpoint | Slipped |
| CRDL | CardiolRx MAVERIC Phase 3 trial (topline) | mid-2027 “Topline results are now anticipated in mid-2027, compared with our previous Q1 2027 guidance.” | PR · Sep 23, 2026 | Now - Dec 14, 2026 | Guide later than CT.gov |
| DMRA | DMR-001 Phase 1/1b CLARITY-101 in mutCALR-driven ET and MF | beginning mid-2027 “Advancing from the presentation of these data into the clinic within weeks reflects the pace we intend to keep, and we're eager to present initial clinical evidence of DMR-001's un” | PR · Aug 10, 2026 | Est. Jul 16, 2027 guidance midpoint | — |
| HRMY | WAKIX (pitolisant) TEMPO Phase 3 (PWS) topline | mid-2027 “Topline data expected in mid-2027 and anticipated PDUFA date in 2028” | PR · Aug 4, 2026 | Est. Jul 16, 2027 guidance midpoint | — |
| IDYA | darovasertib + crizotinib OptimUM-02 prespecified interim OS | mid-2027 “IDEAYA plans to provide an update on the OS data as part of the prespecified interim analysis expected in mid-2027.” | PR · Aug 4, 2026 | Est. Jul 16, 2027 guidance midpoint | Slipped |
| KLRA | ribupatide US Phase 2b high-dose obesity | mid-2027 “Ribupatide injection: U.S. Phase 2b high dose obesity data anticipated in mid-2027; global Phase 3 obesity data anticipated in 2028” | PR · Aug 12, 2026 | Est. Jul 16, 2027 guidance midpoint | — |
| MESO | Rexlemestrocel-L Pivotal Phase 3 MSB-DR004 study in chronic low back pain | Mid-CY2027 “Top-line results are expected in mid-CY2027 after the last treated patient has completed 12 months follow-up.” | PR · Aug 16, 2026 | Est. Jul 16, 2027 guidance midpoint | — |
| SMMT | ivonescimab + casdatifan (RCC) Combination study with casdatifan (HIF-2a inhibitor) in renal cell carcinoma (Arcus collaboration) | data by mid-2027 “Data from the study under this collaboration agreement is expected to be generated by mid-2027.” | PR · Jul 23, 2026 | Est. Jul 16, 2027 guidance midpoint | — |
| VCRE | buloxibutid ASPIRE Phase 2b in idiopathic pulmonary fibrosis | mid-2027 “Recruitment was completed ahead of schedule, positioning the company to report topline results in mid2027.” | PR · 2026-09 | Est. Jul 16, 2027 guidance midpoint | — |
| VRCA | YCANTH (VP-102) Pivotal Phase 3 COVE-3 trial of YCANTH (VP-102) in common warts: topline data | mid-2027 “We anticipate topline data from COVE-2 in the first quarter of 2027 and currently expect the remaining topline data for the program will be available by mid-2027.” | PR · Aug 27, 2026 | Est. Jul 16, 2027 guidance midpoint | Slipped |
| VSTM | avutometinib plus defactinib Phase 3 RAMP 301 trial of avutometinib plus defactinib in recurrent low-grade serous ovarian cancer: primary endpoint topline readout · NCT06072781 | mid-2027 “Report a topline readout of the primary endpoint in the RAMP 301 trial in mid-2027.” | PR · Aug 6, 2026 | Est. Jul 16, 2027 guidance midpoint | Slipped |
| AIM | Ampligen plus Imfinzi DURIPANC study in pancreatic cancer, overall survival analysis · NCT05927142 | Q3 2027 “We anticipate topline results from the DURIPANC study in Q1 2027, followed by a detailed analysis of overall survival in Q3 2027.” | PR · Sep 22, 2026 | Est. Aug 15, 2027 quarter midpoint | Slipped |
| ALGS | pevifoscorvir sodium B-SUPREME study, topline data · NCT06963710 | late Q3 2027 “Topline data are expected to be available in late Q3 2027.” | Filing · Aug 6, 2026 | — | — |
| ANNX | vonaprument ARCHER II Phase 3 in geographic atrophy, Month 24 final completion | Q3 2027 “Next Milestones: Month 15 primary endpoint on track for the fourth quarter of 2026, with final trial completion, including the Month 24 primary endpoint expected in the third quart” | PR · Aug 12, 2026 | Dec 12, 2026 - Jan 23, 2027 | Slipped |
| BCRX | navenibart Phase 3 ALPHA-ORBIT in hereditary angioedema · NCT06842823 | Q3 2027 “The program remains on track to report top-line results from both doses in Q3 2027.” | PR · Aug 5, 2026 | Jan 12 - Feb 23 | Guide later than CT.gov |
| KPRX | KIO-301 ABACUS-2 Phase 2 in late-stage retinitis pigmentosa | Q3 2027 “We expect the last patient, first visit in the first quarter of 2027 with topline data in the third quarter of 2027.” | PR · Aug 7, 2026 | Est. Aug 15, 2027 quarter midpoint | — |
| STOK | zorevunersen Phase 3 EMPEROR in Dravet syndrome · NCT06872125 | Q3 2027 “Stoke completed enrollment in the United States, United Kingdom and Japan in June 2026, and a data readout is anticipated in the third quarter of 2027 to support the submission of ” | PR · Sep 3, 2026 | Est. Aug 15, 2027 quarter midpoint | — |
| TOVX | VCN-01 (zabilugene almadenorepvec) VIRAGE2 Phase 2a in first-line metastatic pancreatic ductal adenocarcinoma | Q3 2027 “Enrollment into the VIRAGE2 trial is expected to be completed in H2 2026 and initial pharmacodynamic and safety/tolerability data are anticipated by Q3 2027.” | PR · Aug 6, 2026 | Est. Aug 15, 2027 quarter midpoint | — |
| TRAX | ANB033 Phase 1b in eosinophilic esophagitis | Q3 2027 “followed by top-line data from our Phase 1b trial of ANB033 in eosinophilic esophagitis in Q3 2027.” | PR · Aug 12, 2026 | Est. Aug 15, 2027 quarter midpoint | Slipped |
| VALN | LB6V (Lyme disease vaccine candidate, partner Pfizer) regulatory decisions (partner-controlled; Pfizer) | next 12 months “Regulatory decisions are expected in the next twelve months.” | PR · Aug 13, 2026 | Est. May 8, 2027 guidance midpoint | — |
| AKBA | ebribafusp Phase 2 open-label basket trial, initial data · NCT06419205 | 2027 “The Phase 2 basket trial is open-label, and Akebia expects to report initial data in 2027.” | Filing · Aug 5, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| AKTS | AKY-2519 Phase 1b in mCRPC, preliminary data · NCT07581184 | 2027 “Expect preliminary data from Phase 1b mCRPC clinical trial in 2027.” | PR · Aug 13, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| ALT | pemvidutide RESTORE study, topline data · NCT07009860 | H2 2027 “The Company expects to report topline data in the second half of 2027” | PR · Aug 12, 2026 | Est. Sep 30, 2027 half midpoint | — |
| ANL | AN4035 Phase I in CEACAM5-enriched RAS-addicted solid tumors | 2H 2027 “The Company is on track to dose the first patient with AN4035 in the second half of 2026, and initial clinical data is expected to be available in the second half of 2027.” | PR · Aug 14, 2026 | Est. Sep 30, 2027 half midpoint | — |
| ANRO | ALTO-207 PACE-1 Phase 2b adjunctive in treatment-resistant depression | 2H 2027 “Enrollment in the ongoing, potentially registrational, Phase 2b trial of ALTO-207 as an adjunctive treatment in approximately 178 adults with TRD is on track with topline data expe” | PR · Aug 12, 2026 | Est. Sep 30, 2027 half midpoint | — |
| ANTX | epetraborole EBO-PV-201 Phase 2 Part 1 | throughout 2027 “The Company anticipates releasing Part 1 data periodically throughout 2027.” | PR · Aug 11, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| ARDX | tenapanor (IBSRELA) ACCEL Phase 3 in chronic idiopathic constipation | 2H 2027 “Enrollment in ACCEL is expected throughout 2026, with topline data read out in the second half of 2027.” | PR · Jan 28, 2026 | Now - Nov 24, 2026 | Guide later than CT.gov |
| ARGX | efgartigimod UNITY registrational in Sjögren’s disease | 2H 2027 “Topline results from registrational UNITY study (Sjogren’s disease) expected in second half of 2027” | PR · Jul 23, 2026 | Est. Sep 30, 2027 half midpoint | Slipped |
| ARGX | empasiprubart EMVIGORATE and EMNERGIZE registrational in CIDP | 2H 2027 “Topline results from registrational EMVIGORATE and EMNERGIZE studies (CIDP) expected in second half of 2027” | PR · Jul 23, 2026 | Est. Sep 30, 2027 half midpoint | Slipped |
| AURA | bel-sar CoMpass Phase 3 in early choroidal melanoma | 2H 2027 “Phase 3 CoMpass trial fully enrolled with 108 patients, exceeding enrollment target; on track for topline data in 2H 2027.” | PR · Aug 11, 2026 | Est. Sep 30, 2027 half midpoint | — |
| AUTL | obe-cel CATULUS Phase 2 in pediatric relapsed/refractory B-ALL | end of 2027 “The Phase 2 portion of the ongoing CATULUS trial of obe-cel in pediatric relapsed or refractory (r/r) B-cell precursor ALL (B-ALL) patients is on track and data are expected to be ” | PR · Aug 11, 2026 | — | Slipped |
| AVLN | AP01 MIST Phase 2b in progressive pulmonary fibrosis | 2H 2027 “Topline data are anticipated in the second half of 2027.” | PR · Aug 12, 2026 | Est. Sep 30, 2027 half midpoint | — |
| AVLN | AP02 AURA Phase 2 in IPF | late 2027 “The 12-week study is designed to enroll 160 patients to assess safety and efficacy, as measured by FVC, with topline data anticipated in late 2027.” | PR · Jun 3, 2026 | Jan 12 - Feb 23 | Guide later than CT.gov |
| AXSM | solriamfetol Phase 3 SUSTAIN topline in shift work disorder | 2027 “The Company anticipates topline results from the SUSTAIN Phase 3 trial in 2027.” | Filing · Aug 10, 2026 | Jan 12 - Feb 23 | Slipped |
| BMRN | BMN 333 registration-enabling Phase 2/3 study in achondroplasia, data update from dose-finding segment | 2027 “The Phase 2/3 study is enrolling, with a data update expected in 2027.” | PR · Aug 6, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| BRVE | BHB-1893 Interim analysis from Phase 3 LIONHEART-HCM | 2H 2027 “We continue to expect results from an interim analysis from LIONHEART-HCM in the second half of 2027.” | PR · Sep 8, 2026 | Est. Sep 30, 2027 half midpoint | — |
| CABA | rese-cel BLA submission | 2H 2027 “Registrational RESET-Myositis clinical data on track to be reported in mid-2027 to support 2H27 BLA submission for rese-cel” | PR · Aug 13, 2026 | Est. Sep 30, 2027 half midpoint | Slipped |
| CBIO | CR-002 Global Phase 1/2 trial in solid tumors proof-of-concept | H2 2027 “Crescent is on track to submit an IND application to the U.S. Food and Drug Administration (FDA) for CR-002 in mid-2026 to support the initiation of a global Phase 1/2 trial in sol” | PR · Jul 30, 2026 | Est. Sep 30, 2027 half midpoint | — |
| CBIO | CR-003 + CR-001 Phase 1/2 combination trial of CR-003 and CR-001 | year-end 2027 “A Phase 1/2 combination trial of CR-003 and CR-001 is expected to initiate in the first half of 2027, with initial data anticipated by year-end 2027.” | PR · Jul 30, 2026 | — | — |
| CCCC | cemsidomide Phase 2 MOMENTUM trial (initial investigator-assessed ORR) | H2 2027 “The initial investigator-assessed overall response rate (ORR) data are expected in the second half of 2027.” | PR · Aug 11, 2026 | Est. Sep 30, 2027 half midpoint | Slipped |
| CGTX | zervimesine START Phase 2 in early Alzheimer's (topline) | H2 2027 “START Phase 2 data in early Alzheimer's... Topline ETA 2H 2027” | Deck · Jun 4, 2026 | Est. Sep 30, 2027 half midpoint | — |
| CLDX | barzolvolimab BLA submission (EMBARQ-CSU1/2 Phase 3) · NCT06445023 | 2027 “plans to submit a Biologics License Application (BLA) to the FDA in 2027” | PR · Sep 22, 2026 | Nov 12 - Dec 24 | Guide later than CT.gov |
| DMRA | DMR-003 first regulatory submission | 2027 “DMR-003 (T-cell engager anti-mutCALR/CD3 bispecific antibody): first regulatory submission expected in 2027” | PR · Aug 10, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| DNLI | DNL593 Phase 1/2 study in FTD-GRN | 2027 “Denali now expects results from the study in 2027, updated from its prior expectation of results by the end of 2026.” | PR · Aug 6, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| DNLI | DNL921 Phase 1/1b study in Alzheimer's disease | 2027 “Safety and clinical proof-of-concept data from the ongoing Phase 1/1b study of DNL921 in healthy volunteers and participants with Alzheimer's disease are expected in in 2027.” | PR · Aug 6, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| DNLI | DNL952 Phase 1 study in late-onset Pompe disease | 2027 “Dosing of participants with late-onset Pompe disease began in the Phase 1 study of DNL952 in the second quarter of 2026, and initial clinical data are expected in 2027.” | PR · Aug 6, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| DNLI | Zafinofusp alfa BLA submission and potential accelerated approval for Sanfilippo syndrome type A | 2027 “Denali expects a Biologics License Application (BLA) submission and potential accelerated approval for zafinofusp alfa for Sanfilippo syndrome type A in 2027.” | PR · Aug 6, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| DSGN | DT-168 Phase 2 biomarker trial in FECD | 2027 “Data is now expected in 2027 due to a delay in the anticipated supply of DT-168 blow-fill-seal eye droppers, moved from prior 2H 2026 guidance.” | PR · Aug 3, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| DSGN | DT-818 Phase 1 MAD trial in myotonic dystrophy type 1 | 2027 “Design anticipates reporting data from this study in 2027.” | PR · Aug 3, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| ELOX | exaluren Phase 2b in nonsense mutation Alport syndrome; planned Phase 2 in ADPKD | mid-2027 (initial 16-week NMAS); end 2027 (final NMAS); mid-2028 (ADPKD) “The Company anticipates topline data from the initial 16-week placebo-controlled portion of the study by mid-2027, with the final readout by the end of 2027. The Company plans to i” | PR · Aug 11, 2026 | — | — |
| ENGN | detalimogene | 2027 “Potential FDA approval decision for detalimogene and platform designation in 2027” | PR · Sep 8, 2026 | Est. Jul 2, 2027 guidance midpoint | Slipped |
| ENTA | zelicapavir LOTUS Phase 2b in pediatric RSV patients | 2027 “Dosing began in LOTUS, our Phase 2b trial of zelicapavir in pediatric patients with RSV in Thailand, with topline data anticipated in 2027.” | PR · Aug 10, 2026 | Jan 12 - Feb 23 | On track |
| ENTA | zelicapavir RESOLVE registrational Phase 2b/3 in high-risk adults with RSV | 2027 “We also announced plans to advance zelicapavir into a registrational Phase 2b/3 trial in high-risk adults with RSV and remain on track to initiate this study, RESOLVE, in the fourt” | PR · Aug 10, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| ERNA | ERNA-101 PROC study | Q4 2027 “Clinical data from the ERNA-101 PROC study are expected in Q4 2027, providing the Company with a series of potential clinical and operational milestones over the coming 12–18 month” | PR · Sep 15, 2026 | Est. Nov 15, 2027 quarter midpoint | Slipped |
| ETON | ASN-001 | 2H 2027 “The Company plans to initiate a bioavailability study and anticipates a New Drug Application ("NDA") submission upon the study's completion in the second half of 2027.” | PR · Aug 13, 2026 | Est. Sep 30, 2027 half midpoint | — |
| ETRA | ipsoprubart Phase 1 in relapsed/refractory T- and NK-cell malignancies | 2H 2027 “We are conducting a Phase 1 clinical trial evaluating ipsoprubart as monotherapy in patients with relapsed/refractory T and NK cell malignancies, with initial data expected in the ” | Filing · Aug 28, 2026 | Est. Sep 30, 2027 half midpoint | — |
| EVMN | EVO756 Phase 2b dose-ranging trial in migraine prophylaxis | 2027 “Top-line data from the trial are expected in 2027.” | PR · Aug 6, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| FDMT | 4D-150 4FRONT-2 Phase 3 in wet AMD | H2 2027 “Enrollment completed in June 2026 with N>500 expected to be randomized; topline data expected in H2 2027” | PR · Aug 13, 2026 | Est. Sep 30, 2027 half midpoint | Slipped |
| FTH | PIK-101 Phase 1b/2 in breast cancer | 2027 “We look forward to reporting initial safety and efficacy data from PIK-101 in 2027.” | PR · Aug 4, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| GLUE | cyclin E1-directed molecular glue degrader | 2027 “Submit an IND application for a cyclin E1-directed MGD in 2027.” | PR · Aug 6, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| HRMY | pitolisant HD Phase 3 ONSTRIDE 1/2 topline | 2027 “Topline data expected in 2027; anticipated PDUFA date in 2028” | PR · Aug 4, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| IFRX | izicopan open-label renal proof-of-concept (aHUS, IgAN, C3G) | 2027 “InflaRx is currently in the planning stages for this development effort, with a goal of generating initial data from these open-label proof-of-concept studies in 2027.” | PR · Aug 6, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| IMA | olevaprubart (IMG-007) ADAPTIVE Phase 2b topline (atopic dermatitis) | Q4 2027 “Topline data from the study is anticipated in the fourth quarter of 2027.” | PR · Aug 5, 2026 | Est. Nov 15, 2027 quarter midpoint | — |
| IMTX | IMA402 + IMA401 Phase 1b bispecific combination in squamous NSCLC | 2027 “Combination cohort in sqNSCLC enrolling patients with first data expected in 2027” | PR · Aug 18, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| IMVT | IMVT-1402 potentially registrational trials in Graves' disease and generalized myasthenia gravis | 2027 “In calendar year 2027, topline data are anticipated for the potentially registrational trials evaluating IMVT-1402 in GD and MG.” | PR · Aug 6, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| IONS | obudanersen (ION582) Phase 3 REVEAL in Angelman syndrome | H2 2027 “Topline data from the REVEAL study is expected in the second half of 2027.” | PR · Jul 6, 2026 | Est. Sep 30, 2027 half midpoint | — |
| JBIO | JADE101 Phase 2 JUNIPER in IgA nephropathy | 2027 “Phase 2 clinical trial in patients with IgA nephropathy underway, with interim clinical data expected in 2027” | PR · Jun 1, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| KLRA | KAI-7535 global Phase 2 obesity | 2027 “KAI-7535: Global Phase 2 obesity data anticipated in 2027” | PR · Aug 12, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| KRSA | KRSA-028 KRSA-028 Phase 1 in healthy volunteers / proof-of-concept in Alzheimer's | mid-2027; Q4 2027-Q1 2028 “The Company is advancing KRSA-028 toward the clinic, with Phase 1 healthy volunteer data expected in mid-2027 and interim proof-of-concept data evaluating amyloid plaque clearance ” | PR · Sep 8, 2026 | Est. Nov 15, 2027 quarter midpoint | — |
| KRYS | KB408 SERPENTINE-1 in alpha-1 antitrypsin deficiency · NCT06049082 | 2027 “The Company expects to report interim study results in 2027.” | PR · Aug 3, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| KYMR | KT-621 (BREADTH) BREADTH Phase 2b in asthma | late 2027 “The Company expects to report data in late 2027.” | PR · Aug 5, 2026 | Est. Oct 31, 2027 guidance midpoint | — |
| LONA | lasofoxifene ELAINE-3 Phase 3 in ER+, HER2-negative, ESR1-mutated metastatic breast cancer | H2 2027 “We have enrolled 495 patients and remain on track to complete enrollment of ELAINE-3 in the fourth quarter of 2026 with topline data expected in the second half of 2027.” | PR · Aug 14, 2026 | Est. Sep 30, 2027 half midpoint | — |
| LSTA | MAR001 MAR001 Phase 2b in severe hypertriglyceridemia | Q4 2027 “Both studies are expected to report topline data in the fourth quarter of 2027.” | PR · Sep 17, 2026 | Est. Nov 15, 2027 quarter midpoint | — |
| LSTA | MAR002 MAR002 Phase 2 in acromegaly | Q4 2027 “Both studies are expected to report topline data in the fourth quarter of 2027.” | PR · Sep 17, 2026 | Est. Nov 15, 2027 quarter midpoint | — |
| LTGO | LTG-321 LTG-321 Phase 2 in knee osteoarthritis | H2 2027 “Expect to report topline results from the Phase 2 clinical trial in the second half of 2027.” | PR · Sep 3, 2026 | Est. Sep 30, 2027 half midpoint | — |
| LTGO | onzotrigine onzotrigine Phase 3 in acute pain | H2 2027 “Expect to report topline results from the Phase 3 bunionectomy and open-label safety clinical trials in the second half of 2027.” | PR · Sep 3, 2026 | Est. Sep 30, 2027 half midpoint | — |
| LXEO | LX2006 SUNRISE-FA 2 pivotal trial in Friedreich ataxia cardiomyopathy | H2 2027 “Topline data readout expected in second half of 2027” | PR · Aug 12, 2026 | Est. Sep 30, 2027 half midpoint | — |
| MAZE | MZE782 CIPheR Phase 2 in phenylketonuria | 2027 “Topline data from the trial is expected in 2027.” | PR · Aug 11, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| MDGL | resmetirom (Rezdiffra) F4-C MAESTRO Outcomes study (event-driven) | 2027 “First, our F4-C MAESTRO Outcomes study, which is an event-driven trial that we expect to read out in 2027.” | Call · Jul 30, 2026 | Jan 12 - Feb 23 | On track |
| MGTX | AAV2-hAQP1 Pivotal Phase 2 AQUAx2 study in radiation-induced xerostomia · NCT05926765 | End 2027 (BLA filing and potential approval, if AQUAx2 positive) “which, if positive, would support a BLA filing and potential approval targeted for the end of 2027, with U.S. launch in 2028.” | PR · Aug 13, 2026 | — | — |
| MOLN | MP0317 Phase 2 TACTIC study of MP0317 | 2027 “A data update from the trial is expected in 2027, and completion of the study in 2028.” | PR · Jul 16, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| MPLT | ML-007C-MA Phase 2b VISTA trial | H2 2027 “Topline results from VISTA are expected in the second half of 2027.” | PR · Aug 13, 2026 | Est. Sep 30, 2027 half midpoint | — |
| MRNA | Intismeran autogene Phase 2 muscle-invasive bladder cancer study | 2027 “The muscle invasive bladder cancer study completed enrollment earlier this year, and we currently expect the readout to be more likely in 2027.” | Call · Jul 31, 2026 | Est. Jul 2, 2027 guidance midpoint | Slipped |
| NBIX | Direclidine Phase 3 studies in schizophrenia | 2027 “With multiple important clinical milestones in 2027, including Phase 3 readouts for osavampator in major depressive disorder and direclidine in schizophrenia, we are building an en” | PR · Jul 30, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| NBIX | osavampator (NBI-1065845) Phase 3 trials in major depressive disorder | 2027 “With multiple important clinical milestones in 2027, including Phase 3 readouts for osavampator in major depressive disorder and direclidine in schizophrenia, we are building an en” | PR · Jul 30, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| NBP | VIS-101 Global Phase 3 program in neovascular AMD | 2027 “2027: Initiate global Phase 3 program in nAMD” | PR · Aug 20, 2026 | Est. Jul 2, 2027 guidance midpoint | Slipped |
| NERV | Roluperidone Phase 3 MIN-101C19 Phase A study in schizophrenia | H2 2027 “We remain focused on execution and on track for topline efficacy data in the second half of 2027.” | PR · Aug 7, 2026 | Est. Sep 30, 2027 half midpoint | — |
| NGNE | NGN-401 Embolden registrational trial in Rett syndrome | 2H 2027 “The clinically meaningful benefit observed across all participants, including 100% of treated participants improving on CGI-I and gaining an average of 4.7 developmental milestones” | PR · Aug 11, 2026 | Est. Sep 30, 2027 half midpoint | — |
| NRXP | NRX-100 NRX-100 NDA approval for suicidal depression | 2027 “With alignment on the drug packaging matter, the Company is now poised to finalize its NDA, aiming for 2027 approval.” | PR · Aug 17, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| NVS | ianalumab SLE and lupus nephritis Phase 3 readouts | 2027 “We're on track for the ITP first-line readout in the second half of 2026, the SLE and lupus nephritis phase III readouts in 2027, and the systemic sclerosis phase II readout as wel” | Call · Jul 21, 2026 | Est. Jul 2, 2027 guidance midpoint | Slipped |
| OBX | amsoki-cel (OBX-115) Agni-01 registration-enabling cohort in advanced melanoma · NCT06060613 | year-end 2027 “We anticipate reporting topline data from the registration-enabling cohort by year-end 2027.” | PR · Aug 5, 2026 | — | Slipped |
| ODTX | OD-001 Phase 2b monotherapy and Phase 2a vedolizumab-combination induction data | 2H 2027 “Initiate a Phase 2b monotherapy trial and Phase 2a combination trial with vedolizumab in the second half of 2026, with topline induction data from both studies expected in the seco” | PR · Aug 4, 2026 | Est. Sep 30, 2027 half midpoint | Slipped |
| PALI | PALI-2108 ASCENTRA-UC global Phase 2b in moderately to severely active ulcerative colitis, primary efficacy results from 12-week induction | H2 2027 “Primary efficacy results from the study's 12-week induction period are expected in the second half of 2027.” | PR · Sep 23, 2026 | Est. Sep 30, 2027 half midpoint | — |
| PLX | PRX-115 RELEASE Phase 2 in uncontrolled gout, top-line results · NCT07280156 | H2 2027 “The Company continues to anticipate top-line results in the second half of 2027.” | PR · Aug 12, 2026 | Est. Sep 30, 2027 half midpoint | — |
| PRME | PM647 AATD program, initial clinical data | 2027 “Submission of an IND and/or CTA for PM647 in AATD in the third quarter of 2026, initial clinical data in 2027.” | PR · Aug 6, 2026 | Est. Jul 2, 2027 guidance midpoint | Slipped |
| PRME | PM577a global Phase 1/2 study in Wilson disease, initial clinical data | 2027 “Continue study startup activities for the global Phase 1/2 clinical trial of PM577a in WD, initial clinical data in 2027.” | PR · Aug 6, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| PVLA | QTORIN rapamycin Phase 2 LOTU trial for clinically significant angiokeratomas, topline results | H2 2027 “Topline results from the Phase 2 LOTU trial of QTORIN rapamycin for clinically significant angiokeratomas expected in the second half of 2027” | PR · Aug 4, 2026 | Est. Sep 30, 2027 half midpoint | Slipped |
| REGN | cemdisiran cemdisiran MAA review decision in Europe | 2H 2027 “A decision from the European Commission is anticipated in the second half of 2027.” | PR · Jul 30, 2026 | Est. Sep 30, 2027 half midpoint | Slipped |
| RGNX | RGX-202 RGX-202 potential approval under accelerated approval | 2H 2027 “The Company is on track to initiate a BLA submission in Q3 2026 under the accelerated approval pathway, supporting potential approval in 2H 2027.” | Filing · Aug 6, 2026 | Nov 12 - Dec 24 | Slipped |
| RNA | ATR 1072 Corventis study in PRKAG2 syndrome (initial proof-of-concept data) | 2H 2027 “Clinical site initiation activities are currently underway, and Atrium expects the first participant to be enrolled by the end of 2026. Initial trial data demonstrating proof of co” | PR · Jul 14, 2026 | Est. Sep 30, 2027 half midpoint | — |
| RNXT | IAG (intra-arterial gemcitabine) Phase III TIGeR-PaC trial in LAPC (initial topline data) · NCT03257033 | 2H 2027 “Following completion of the trial, initial top line trial data is expected to be available during the second half of 2027.” | PR · Aug 11, 2026 | Est. Sep 30, 2027 half midpoint | — |
| RVMD | daraxonrasib RASolve 301 Phase 3 in RAS-mutant NSCLC | 2027 “In lung cancer, we expect to complete enrollment in RASolve 301 this year, supporting an initial readout in 2027.” | Call · Aug 12, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| SABS | SAB-142 SAFEGUARD Phase 2b in type 1 diabetes (topline) | 2H 2027 “Enrollment remains on track for completion in Q4 2026, with topline data expected in 2H 2027.” | PR · Aug 6, 2026 | Est. Sep 30, 2027 half midpoint | — |
| SCYX | SCY-770 (Phase 2) Phase 2 proof-of-concept in ADPKD | H2 2027 “SCYNEXIS remains on track to initiate its Phase 2 proof-of-concept study of SCY-770 in ADPKD patients in Q4 2026, with an anticipated early efficacy readout in the second half of 2” | PR · Aug 10, 2026 | Est. Sep 30, 2027 half midpoint | — |
| SNDX | revumenib Phase 1/2 proof-of-principle in myelofibrosis | H2 2027 “a Phase 1/2 proof-of-principle trial of revumenib in MF that is expected to initiate in the fourth quarter of 2026 with initial clinical data expected in the second half of 2027.” | PR · Aug 4, 2026 | Est. Sep 30, 2027 half midpoint | — |
| SNY | brivekimig Phase 2b in hidradenitis suppurativa | 2027 “Next year, we expect phase II-B results for brivekimig and hidradenitis suppurativa” | Call · Jul 30, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| SNY | frexalimab Phase 3 in relapsing multiple sclerosis | 2027 “followed by several phase III readouts, including frexalimab in relapsing multiple sclerosis, riliprubart in CIDP compared to IVIG, and our pneumococcal and yellow fever vaccines.” | Call · Jul 30, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| SNY | pneumococcal conjugate vaccine Phase 3 pneumococcal vaccine | 2027 “followed by several phase III readouts, including frexalimab in relapsing multiple sclerosis, riliprubart in CIDP compared to IVIG, and our pneumococcal and yellow fever vaccines.” | Call · Jul 30, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| SNY | riliprubart Phase 3 in CIDP (vs IVIG) | 2027 “followed by several phase III readouts, including frexalimab in relapsing multiple sclerosis, riliprubart in CIDP compared to IVIG, and our pneumococcal and yellow fever vaccines.” | Call · Jul 30, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| SNY | yellow fever vaccine Phase 3 yellow fever vaccine | 2027 “followed by several phase III readouts, including frexalimab in relapsing multiple sclerosis, riliprubart in CIDP compared to IVIG, and our pneumococcal and yellow fever vaccines.” | Call · Jul 30, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| SRZN | SZN-8141 DUET Phase 1b/2a in diabetic macular edema (DME) | H2 2027 (initial data) “Expect to initiate SZN-8141 Phase 1b/2a study, DUET, by year-end 2026 with initial data anticipated in the second half of 2027” | PR · Aug 6, 2026 | Est. Sep 30, 2027 half midpoint | — |
| TARA | TARA-002 (LM BLA) lymphatic malformations, BLA submission | H2 2027 “we intend to submit a Biologics License Application, or BLA, for TARA-002 in LMs based on the results of the pivotal STARBORN-1 trial in the second half of 2027” | Filing · Aug 11, 2026 | Est. Sep 30, 2027 half midpoint | — |
| TRVI | Haduvio (nalbuphine ER) OCEAN-2 Phase 3 in IPF-related chronic cough | 2H 2027 “The Company plans to initiate the 12-week fixed dosing OCEAN-2 trial, in the third quarter of 2026, with topline results expected in the second half of 2027.” | PR · Aug 6, 2026 | Est. Sep 30, 2027 half midpoint | — |
| TRVI | Haduvio (nalbuphine ER) LAKE Phase 2b in refractory chronic cough (RCC) | 2H 2027 “The Company initiated the Phase 2b LAKE trial in patients with RCC in the second quarter of 2026. The protocol includes a sample size re-estimation (SSRE) analysis once 50% of the ” | PR · Aug 6, 2026 | Est. Sep 30, 2027 half midpoint | — |
| TVTX | pegtibatinase pivotal Phase 3 HARMONY Study in classical homocystinuria (HCU) | 2H 2027 “The Company is continuing to enroll new patients in the pivotal Phase 3 HARMONY Study, with topline data anticipated in 2H 2027.” | PR · Aug 4, 2026 | Est. Sep 30, 2027 half midpoint | — |
| UPB | verekitug VENTURE Phase 2 in chronic obstructive pulmonary disease (COPD) · NCT06981078 | 2H 2027 “The Company has completed enrollment in the VENTURE trial in COPD with 481 participants. Data are expected in the second half of 2027.” | PR · Aug 11, 2026 | Est. Sep 30, 2027 half midpoint | — |
| UPB | verekitug VALOUR Phase 2 severe-asthma extension (VALIANT participants) · NCT06966479 | 2H 2027 “The study completed enrollment in March 2026 with more than 90% retention of eligible participants from the Phase 2 VALIANT study. Data from the study are expected in the second ha” | PR · Aug 11, 2026 | Est. Sep 30, 2027 half midpoint | — |
| UTHR | nebulized Tyvaso potential FDA approval in idiopathic pulmonary fibrosis (IPF) | 2027 “By next year, we expect potential approvals for Nebulized Tyvaso in IPF and ralinepag tablets in PAH, two potentially transformative, multi-billion-dollar catalysts that could sign” | PR · Aug 5, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| UTHR | ralinepag tablets potential FDA approval in pulmonary arterial hypertension (PAH) | 2027 “By next year, we expect potential approvals for Nebulized Tyvaso in IPF and ralinepag tablets in PAH, two potentially transformative, multi-billion-dollar catalysts that could sign” | PR · Aug 5, 2026 | Jan 12 - Feb 23 | On track |
| VERU | enobosarm PLATEAU Phase 3b trial of enobosarm: final topline clinical data | Q4 2027 “Final topline clinical data is expected in the fourth quarter of calendar year 2027.” | PR · Aug 10, 2026 | Est. Nov 15, 2027 quarter midpoint | Slipped |
| VKTX | VK2735 Phase 3 VANQUISH-1 trial of weekly subcutaneous VK2735 in obesity | 2H 2027 “Viking expects both studies to report data in the second half of 2027.” | PR · Sep 17, 2026 | Est. Sep 30, 2027 half midpoint | — |
| VKTX | VK2735 Phase 3 VANQUISH-2 trial of weekly subcutaneous VK2735 in obesity with type 2 diabetes | 2H 2027 “Viking expects both studies to report data in the second half of 2027.” | PR · Sep 17, 2026 | Est. Sep 30, 2027 half midpoint | — |
| VOGX | mizagliflozin Phase 2b EMERGE study of mizagliflozin: topline results | 2027 “We initiated study startup activities for our Phase 2B EMERGE study and are targeting topline results in 2027.” | PR · Aug 10, 2026 | Est. Jul 2, 2027 guidance midpoint | — |
| XLO | XTX501 Phase 1/2 trial of XTX501: initial Phase 1 data in metastatic non-small cell lung cancer · NCT07688577 | 2H 2027 “we plan to report initial Phase 1 data in patients with metastatic NSCLC in the second half of 2027.” | PR · Aug 12, 2026 | Est. Sep 30, 2027 half midpoint | — |
| XNCR | XmAb942 Phase 2b XENITH-UC of XmAb942 in moderately to severely active ulcerative colitis | 2H 2027 “We expect to complete a blinded interim analysis around year-end 2026 and complete the primary endpoint analysis for the study's 12-week induction period during the second half of ” | PR · May 6, 2026 | Est. Sep 30, 2027 half midpoint | — |
| YARW | YB-101 Phase 2a/2b trial of YB-101 in Graves’ disease: Phase 2a portion data | 2H 2027 “Data from the Phase 2a portion of the trial are expected in the second half of 2027.” | PR · Jul 27, 2026 | Est. Sep 30, 2027 half midpoint | — |
| YARW | YB-101 Partner GenSci Phase 1 MAD trial of YB-101 in thyroid eye disease: data | 2H 2027 “Data from the MAD portion of GenSci’s Phase 1 TED trial are anticipated in the second half of 2027 and will inform future development plans for YB-101 in TED globally.” | PR · Jul 27, 2026 | Est. Sep 30, 2027 half midpoint | — |
| OCUL | OTX-TKI (AXPAXLI) SOL-R Phase 3 non-inferiority trial of AXPAXLI in wet AMD | Q1 2028 “Topline data for SOL-R are now expected during the first quarter of 2028.” | PR · Jun 17, 2026 | Est. Feb 15, 2028 quarter midpoint | — |
| ZYME | zanidatamab Phase 3 EmpowHER-303 trial of zanidatamab: top-line data | end of 2027 / early 2028 “The EmpowHER-303 trial is expected to complete patient enrollment in mid-2027 with top-line data expected by the end of 2027 or early 2028.” | PR · Aug 6, 2026 | Est. Feb 14, 2028 guidance midpoint | — |
| MOLN | MP0712 Phase 1/2a study of MP0712 | Initial data within months; comprehensive dataset in 2027 “Initial data from the MP0712 Phase 1/2a study are expected within the next months, with a more comprehensive dataset on safety and efficacy in 2027.” | PR · Jul 6, 2026 | — | — |
| MRNA | Intismeran autogene Phase 2 adjuvant renal-cell carcinoma study | 2026 or 2027 (event-driven) “The renal cell carcinoma study has been fully enrolled since the second quarter of 2025, so it is possible that the threshold for the analysis could be reached this year. However, ” | Call · Jul 31, 2026 | — | — |
| SLS | galinpepimut-S (GPS) Phase 3 REGAL in AML second complete remission (CR2); event-driven final analysis at 80th death event | event-driven “For GPS, we are approaching the pre-specified 80th event in the Phase 3 REGAL trial marking a critical step toward the final efficacy analysis and, if successful, a potential BLA s” | PR · Aug 11, 2026 | — | — |
| AGMB | AGMB-447 Phase 1b IPF patient cohort, topline | coming months (guided Aug 2026) “We expect to report topline results from the IPF patient cohort in the coming months.” | Filing · Aug 6, 2026 | — | Reported ✓ Sep 14, 2026 |
| AGMB | ontunisertib STENOVA Part B open-label extension in FSCD patients, topline | coming months (guided Aug 2026) “We are progressing the OLE part of the STENOVA study (Part B) with ontunisertib in FSCD patients, with topline results expected in the coming months.” | Filing · Aug 6, 2026 | — | Reported ✓ Oct 1, 2026 |
| MIRM | Zilurgisertib Zilurgisertib NDA in fibrodysplasia ossificans progressiva | September 26, 2026 (PDUFA target action date) “Prescription Drug User Fee Act (PDUFA) target action date for the zilurgisertib NDA is September 26, 2026.” | PR · Aug 5, 2026 | — | Reported ✓ Sep 25, 2026 |
| ACET | prula-cel (formerly ADI-001) Phase 1 in systemic lupus erythematosus with or without lupus nephritis, topline · NCT06375993 | September 2026 “Prula-cel topline data from SLE patients with or without LN expected in September 2026.” | Filing · Sep 1, 2026 | — | Reported ✓ Sep 28, 2026 |
| ARCT | ARCT-810 Phase 2 in OTC deficiency, data and regulatory plan | Q3 2026 “We expect to communicate both the data and regulatory plan for OTC deficiency program in Q3 2026.” | Call · Aug 6, 2026 | — | Reported ✓ Sep 23, 2026 |
| ARGX | efgartigimod ALKIVIA registrational in myositis | Q3 2026 “Topline results from registrational ALKIVIA study (myositis) expected in third quarter of 2026” | PR · Jul 23, 2026 | — | Reported ✓ Oct 8, 2026 |
| BFRI | Ameluz sNDA filing for actinic keratosis label expansion | end of Q3 2026 (planned) “These data support our plan to file a supplemental NDA around the end of the third quarter of 2026 to expand the Ameluz label beyond AKs on the face and scalp to a treatment field ” | Call · Aug 13, 2026 | — | Reported ✓ Sep 14, 2026 |
| BIVI | bezisterim Phase 2 ADDRESS-LC topline in Long COVID | before end of September 2026 “With the last patient's treatment visit completed, and the one-month virtual follow-up nearly complete, we anticipate announcing topline results for ADDRESS-LC before the end of Se” | PR · Aug 31, 2026 | — | Reported ✓ Oct 19, 2026 |
| CNTB | rademikibart Seabreeze STAT COPD Phase 2 study (topline) | September 2026 “Data from Seabreeze STAT COPD study of rademikibart will be available later this month” | PR · Sep 15, 2026 | — | Reported ✓ Sep 30, 2026 |
| CUE | CUE-221 Phase 2 trial in chronic spontaneous urticaria | end of Q3 2026 “Phase 2 data readout in Chronic Spontaneous Urticaria anticipated by the end of the third quarter of 2026.” | PR · Aug 14, 2026 | — | Reported ✓ Sep 20, 2026 |
| DBVT | VIASKIN Peanut BLA submission in children aged 4 through 7 years | Q3 2026 “The Company will take the required time to incorporate that feedback and now anticipates filing of the BLA to occur in the third quarter of 2026.” | PR · Jun 29, 2026 | — | Reported ✓ Sep 29, 2026 |
| IMMP | eftilagimod alfa (efti) TACTI-004 additional/root-cause analysis | Q3 CY26 “the ongoing analysis is expected to provide further insights, with additional results anticipated in Q3 CY26.” | Filing · Aug 3, 2026 | — | Reported ✓ Sep 11, 2026 |
| IMMX | NXC-201 NEXICART-2 update · NCT06097832 | September 2026 “The next NEXICART-2 update is expected late September 2026.” | PR · May 21, 2026 | Jan 12 - Feb 23 | Reported ✓ Sep 29, 2026 |
| INBX | INBRX-106 randomized Phase 2 in HNSCC with pembrolizumab | Q3 2026 “The Company plans to announce progression-free survival (PFS) data from the randomized Phase 2 trial in head and neck squamous cell carcinoma (HNSCC) in combination with pembrolizu” | PR · Aug 6, 2026 | — | Reported ✓ Sep 8, 2026 |
| IVVD | VYD2311 DECLARATION | Q3 2026 “Invivyd continues to expect top-line data from the VYD2311 program around the end of Q3 2026 (prior guide was mid-2026 at initiation, shifted to late Q3 2026 at June 2026 enrollmen” | PR · Sep 1, 2026 | — | Reported ✓ Sep 29, 2026 |
| JAZZ | zanidatamab (Ziihera) HERIZON-GEA-01 doublet in HER2+ 1L GEA | 3Q26 “Top-line results from the second interim overall survival (OS) analysis for the HERIZON-GEA-01 trial doublet regimen are expected in 3Q26.” | PR · Aug 3, 2026 | — | Reported ✓ Aug 31, 2026 |
| KOD | Zenkuda (tarcocimab tedromer) and KSI-501 (tabirafusp tedromer) DAYBREAK Phase 3 in treatment-naive wet AMD · NCT06556368 | September 2026 “We remain on track for September 2026 DAYBREAK Phase 3 topline results evaluating both Zenkuda and KSI-501 in treatment-naive wet AMD.” | PR · Aug 13, 2026 | — | Reported ✓ Sep 28, 2026 |
| MIRM | Brelovitug Phase 3 AZURE-1 study in chronic hepatitis delta virus | Q3 2026 “Brelovitug AZURE-1 and AZURE-4 Phase 3 studies in chronic hepatitis delta virus (HDV) topline results expected in Q3 and Q4 2026, respectively.” | PR · Aug 5, 2026 | — | Reported ✓ Sep 28, 2026 |
| MLTX | Sonelokimab Sonelokimab HS BLA submission | End of September 2026 “With no remaining gaps identified, the pre-BLA process for HS is complete, and the BLA submission to the FDA is planned for the end of September 2026; acceptance, including a decis” | PR · May 10, 2026 | — | Reported ✓ Sep 30, 2026 |
| PRME | PM647 IND and/or CTA submission in AATD | Q3 2026 “Additionally, Prime Medicine expects to submit an IND and/or CTA for PM647 in AATD in the third quarter of 2026.” | PR · Aug 6, 2026 | — | Reported ✓ Sep 24, 2026 |
| QURE | AMT-130 Phase I/II study in Huntington's disease | September 2026 “Topline four-year data from the Phase I/II study of AMT-130 expected in September 2026” | PR · Jul 29, 2026 | — | Reported ✓ Sep 29, 2026 |
| SCYX | SCY-770 (Phase 1) Phase 1 food-effect/PK dose-selection study in ADPKD | Q3 2026 “The study is characterizing the food-effect and defining the pharmacokinetics of two dosing regimens of SCY-770 to support dose selection for the planned Phase 2 study in ADPKD pat” | PR · Aug 10, 2026 | — | Reported ✓ Oct 6, 2026 |
| SRRK | apitegromab spinal muscular atrophy (SMA), FDA BLA under review | September 30, 2026 “Apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA) review by FDA continues to advance with two fill-finish facilities, representing two independent p” | PR · Aug 6, 2026 | — | Reported ✓ Sep 11, 2026 |
| TECX | TX2100 Phase 1a in healthy volunteers | by end of Q3 2026 “The Company expects to report topline results for the TX2100 Phase 1a clinical trial in healthy volunteers by the end of Q3 2026, with detailed data planned to be subsequently pres” | PR · Aug 6, 2026 | — | Reported ✓ Sep 29, 2026 |
| TLSA | foralumab (intranasal) INFORM-MS Phase 2a in multiple sclerosis · NCT06292923 | late Q3 / early Q4 2026 “Topline data is expected in late Q3/early Q4 of 2026, and is planned to be presented at the 10th joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS)” | PR · Jun 25, 2026 | — | Reported ✓ Nov 2, 2026 |
| QTTB | bempikibart SIGNAL-AA Phase 2a Part B late-breaking presentations at EADV Congress 2026 | September 30 - October 3, 2026 “Q32 Bio Inc. (Nasdaq: QTTB) ("Q32 Bio"), a clinical-stage biotechnology company focused on developing innovative therapies for alopecia areata ("AA") and other autoimmune and infla” | PR · Sep 21, 2026 | — | Reported ✓ Oct 1, 2026 |
| SXTP | tafenoquine severe hospitalized babesiosis, interim analysis · NCT06207370 | no later than October 6, 2026 “The outcome of the interim analysis will be disclosed no later than October 6, 2026.” | Source · Jul 29, 2026 | — | Reported ✓ Oct 6, 2026 |
| RCUS | casdatifan ARC-20 platform study data presentation at investor event 2026-10-20 | October 20, 2026 “The event will highlight new data from the ARC-20 platform study, which is evaluating casdatifan, a next-generation HIF-2α inhibitor, alone or in combination, as a first-, second- ” | PR · Sep 22, 2026 | — | Reported ✓ Oct 20, 2026 |
| ALNY | ALN-HTT02 Phase 1 in Huntington's disease, initial results presented at EHDN Clinical Research Congress · NCT06585449 | October 23, 2026 “Alnylam announces today that it will present initial results from the Phase 1 clinical trial of ALN-HTT02 in patients with Huntington's disease at the European Huntington's Disease” | PR · Jul 30, 2026 | — | Reported ✓ Oct 23, 2026 |
| EIKN | EIK1003 Phase 1/2 trial in advanced solid tumors · NCT06253130 | October 23, 2026 “Eikon will present clinical data from its ongoing Phase 1/2 trial of EIK1003 on Friday, October 23 at the ESMO Congress 2026 in Madrid, Spain.” | PR · Aug 13, 2026 | — | Reported ✓ Oct 23, 2026 |
| EIKN | EIK1004 Phase 1/2 trial in ovarian, breast, prostate and pancreatic cancers · NCT06907043 | October 23, 2026 “On Friday, October 23 at the ESMO Congress 2026 in Madrid, Spain, Eikon will also present, for the first time, data from an ongoing Phase 1/2 trial evaluating the safety and effica” | PR · Aug 13, 2026 | — | Reported ✓ Oct 23, 2026 |
| EIKN | EIK1005 Phase 1/2 trial in advanced solid tumors · NCT07262619 | October 23, 2026 “Preliminary safety, tolerability and pharmacokinetic data for EIK1005 will be presented on Friday, October 23 at the ESMO Congress 2026 in Madrid, Spain.” | PR · Aug 13, 2026 | — | Reported ✓ Oct 23, 2026 |
| HCM | savolitinib + osimertinib SAFFRON Phase 3 (full results, ESMO) | October 25, 2026 “The SAFFRON Global Phase III Study has been selected for a Presidential Symposium oral presentation.” | PR · Sep 24, 2026 | — | Reported ✓ Oct 25, 2026 |
| HCM | savolitinib + osimertinib SANOVO Phase 3 (full results, ESMO) | October 26, 2026 “The SANOVO China Phase III Study has been selected for a Proffered Paper oral presentation.” | PR · Sep 24, 2026 | — | Reported ✓ Oct 26, 2026 |
| ARVN | ARV-102 Phase 1 in Parkinson’s disease | October 2026 “Share additional biomarker data from the Phase 1 clinical trial in patients with Parkinson’s disease at the International Congress on Parkinson’s Disease and Movement Disorders (Oc” | PR · Aug 4, 2026 | — | Reported ✓ Oct 7, 2026 |
| BNTC | BB-301 Interim Cohort 1 and Cohort 2 results at ESGCT Annual Congress · NCT06185673 | October 27-30, 2026 “Interim clinical results for Cohort 1 and Cohort 2 will be presented at the 33rd Annual Congress of the European Society of Gene & Cell Therapy in Hamburg, Germany, October 27-30, ” | PR · Sep 14, 2026 | — | Reported ✓ Oct 28, 2026 |
| GANX | rexaceract (GT-02287) Phase 1b | October 2026 “We remain focused on completing the ongoing nine-month extension of our Phase 1b study, with final data expected to be presented at the International Congress of Parkinson's Diseas” | PR · Aug 11, 2026 | — | Reported ✓ Oct 1, 2026 |
| GMAB | petosemtamab updated colorectal cancer data (ESMO) | October 2026 “We are looking forward to sharing with you petosemtamab data with updated results in colorectal cancer presented at ESMO in October.” | Call · Aug 6, 2026 | — | Reported ✓ Oct 25, 2026 |
| IDYA | darovasertib OptimUM-01 updated data (ESMO) | October 2026 “The company plans to present updated ORR, PFS and OS results from approximately 85 efficacyevaluable HLA*A2:01-positive patients, including both first line and pretreated patients,” | PR · Aug 4, 2026 | — | Reported ✓ Oct 19, 2026 |
| IDYA | darovasertib OptimUM-09 updated data (ESMO) | October 2026 “Updated clinical data will also be presented at ESMO from the ongoing Phase 2 OptimUM-09 trial of neoadjuvant darovasertib.” | PR · Aug 4, 2026 | — | Reported ✓ Oct 19, 2026 |
| IMTX | IMA402 Phase 1b PRAME bispecific in multiple cancers | ESMO Congress 2026 “Phase 1b data at recommended Phase 2 dose (RP2D) range across multiple cancers planned for presentation at the ESMO Congress 2026” | PR · Aug 18, 2026 | — | Reported ✓ Oct 24, 2026 |
| MGNX | MGC026 Phase 1 dose-escalation and dose-expansion study | ESMO 2026 Congress (October 2026) “Interim results from the Phase 1 study have been accepted for poster presentation at the European Society for Medical Oncology (ESMO) 2026 Congress in October.” | PR · Aug 13, 2026 | — | Reported ✓ Oct 23, 2026 |
| ODTX | OD-001 Full Phase 2a induction dataset at UEG Week | October 2026 “Updated safety and efficacy results from the full Phase 2a induction dataset, including expansion cohort, as well as assessments of exploratory endpoints, are expected to be presen” | PR · Aug 4, 2026 | — | Reported ✓ Oct 20, 2026 |
| RAPP | RAP-219 Phase 2 trial in bipolar mania | October 2026 “The Phase 2 trial continues to progress, with topline results expected in October 2026.” | PR · Aug 5, 2026 | — | Reported ✓ Oct 20, 2026 |
| TRDA | ENTR-601-45 ELEVATE-45-201 Phase 1/2 in Duchenne muscular dystrophy, Cohort 1 MAD (5 mg/kg) | October 2026 “The Company expects to report data from the Cohort 1 MAD (5 mg/kg) in October 2026.” | PR · Aug 5, 2026 | — | Reported ✓ Oct 14, 2026 |
| VSTM | avutometinib plus defactinib Phase 2 RAMP 201 molecular profiling and tumor biomarker analysis: late-breaking oral presentation at IGCS 2026 · NCT04625270 | October 2026 “today announced that an abstract about molecular profiling and tumor biomarker analysis from the Phase 2 RAMP 201 clinical trial of avutometinib plus defactinib in patients with re” | PR · Sep 24, 2026 | — | Reported ✓ Oct 2, 2026 |
| XNCR | XmAb819 Phase 1 XmAb819 ccRCC expansion cohorts: oral presentation at ESMO 2026 | October 2026 “XmAb819 ccRCC expansion cohorts to be presented in an oral session at ESMO 2026” | PR · Aug 5, 2026 | — | Reported ✓ Oct 26, 2026 |
| CATX | [212Pb]VMT-α-NET Dose-escalation/dose-expansion study, Cohorts 1-3 (ENA 2026 poster) · NCT05636618 | November 20, 2026 “updated data on the Company's [212Pb]VMT-α-NET program have been accepted for presentation as detailed below at the 38th EORTC-NCI-AACR (ENA) Symposium 2026 on Molecular Targets an” | PR · Sep 11, 2026 | — | Reported ✓ Nov 5, 2026 |
| CPIX | ifetroban DMD program (FDA meeting on regulatory pathway) | fall 2026 “We continue to hold discussions with the FDA regarding the regulatory pathway for this program, with another meeting scheduled this fall” | Call · Aug 4, 2026 | Est. Nov 7, 2026 guidance midpoint | Reported ✓ Oct 23, 2026 |
| PYXS | MICVO (monotherapy) Updated MICVO monotherapy data in 2L+ R/M HNSCC | Fall 2026 “We expect to report updated monotherapy data in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (2L+ R/M HNSCC) this fall, followed by updated fir” | PR · Aug 13, 2026 | Est. Nov 7, 2026 guidance midpoint | Reported ✓ Sep 9, 2026 |
| RXRX | REC-4881 Phase 2 in familial adenomatous polyposis (FAP) | November 2026 “REC-4881 (MEK1/2 inhibitor): Additional Phase 2 data in Familial Adenomatous Polyposis (FAP) to be presented at the Presidential Plenary session at leading hereditary GI annual mee” | Filing · Aug 5, 2026 | — | Reported ✓ Nov 2, 2026 |
| ABOS | sabirnetug (ACU193) ALTITUDE-AD Phase 2 in early Alzheimer's disease · NCT06335173 | late 2026 “The Company expects topline results from ALTITUDE-AD in late 2026.” | PR · May 12, 2026 | Est. Nov 7, 2026 guidance midpoint | Reported ✓ Oct 30, 2026 |
| ACET | prula-cel (formerly ADI-001) Phase 1 in systemic sclerosis, clinical update | Q4 2026 “Clinical update in patients with systemic sclerosis expected in the fourth quarter of 2026.” | Filing · Sep 1, 2026 | Est. Nov 15, 2026 quarter midpoint | Reported ✓ Sep 28, 2026 |
| ACIU | ACI-7104 VacSYn Phase 2 in early Parkinson's disease, Part 1 week-100 | H2 2026 “The candidate is currently being investigated in the VacSYn Phase 2 trial, an adaptive, biomarker-based study in patients with early-stage Parkinson's disease, with final Part 1 we” | PR · Aug 11, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Sep 23, 2026 |
| ACRS | ATI-052 Phase 1b proof-of-concept in atopic dermatitis, topline | H2 2026 “Reaffirmed Expectation of Top Line Results in the Second Half of 2026 from Two Ongoing Phase 1b POC Trials of ATI-052: ATI-052 is being assessed in POC trials in both atopic dermat” | Filing · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Oct 27, 2026 |
| ACRS | ATI-052 Phase 1b proof-of-concept in asthma, topline | H2 2026 “Reaffirmed Expectation of Top Line Results in the Second Half of 2026 from Two Ongoing Phase 1b POC Trials of ATI-052: ATI-052 is being assessed in POC trials in both atopic dermat” | Filing · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Oct 27, 2026 |
| ARTV | AlloNK (AB-101) Phase 2a in refractory rheumatoid arthritis (with rituximab) | 2H 2026 “Updated clinical data expected in the second half of 2026 from at least 20 patients with refractory rheumatoid arthritis (RA) treated with AlloNK and rituximab in the ongoing compa” | PR · Sep 8, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Oct 27, 2026 |
| ARTV | AlloNK (AB-101) Phase 2a in Sjögren disease and systemic sclerosis | 2H 2026 “Updated clinical data expected in the second half of 2026 from at least 10 patients with Sjögren disease (SjD) and at least five patients with systemic sclerosis (SSc), each with a” | PR · Sep 8, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Oct 27, 2026 |
| AVBP | firmonertinib FURVENT Phase 3 first-line EGFR exon 20 insertion mutant NSCLC · NCT05607550 | 2H 2026 “Top-line data from the global pivotal FURVENT Phase 3 (NCT05607550) study for first-line EGFR exon 20 insertion mutant NSCLC is anticipated in 2H 2026.” | PR · Aug 12, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Oct 6, 2026 |
| BNTX | gotistobart Phase 3 first interim analysis in 2L+ squamous NSCLC | late 2026 “For gotistobart, we expect a first interim analysis in late 2026 based on the projected event accrual rates.” | Call · Aug 4, 2026 | Est. Nov 7, 2026 guidance midpoint | Reported ✓ Sep 14, 2026 |
| CCCC | cemsidomide Phase 1b trial in combination with elranatamab (dose-escalation update) | H2 2026 “C4T expects to provide an update on the dose escalation progress in the second half of 2026 with data from all cohorts expected in mid-2027.” | PR · Aug 11, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Sep 25, 2026 |
| CORT | relacorilant (Lifyorli) EC decision on EU marketing authorization (ROSELLA) | Q4 2026 “The EC will review the CHMP's opinion and issue a final decision regarding approval in the fourth quarter of 2026.” | PR · Sep 18, 2026 | Est. Nov 15, 2026 quarter midpoint | Reported ✓ Oct 26, 2026 |
| CPIX | ifetroban Phase 2 systemic sclerosis trial (topline) | 2026 “Patient enrollment in the study has been completed, and evaluation of the Phase II study data is underway, with top-line results anticipated this year.” | Call · Aug 4, 2026 | Est. Nov 7, 2026 guidance midpoint | Reported ✓ Oct 23, 2026 |
| CRBU | CB-011 CaMMouflage Phase 1 trial (initial dose-expansion safety and efficacy) · NCT05722418 | H2 2026 “In the second half of 2026, Caribou expects to report initial safety and efficacy from dose expansion on more than 15 patients with a minimum of three months follow up, as well as ” | PR · Aug 13, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Oct 6, 2026 |
| CRSP | CTX310 Phase 1b clinical trial in severe hypertriglyceridemia and refractory hypercholesterolemia | 2H 2026 “The Company also expects to provide a Phase 1b clinical update in the second half of 2026.” | PR · Aug 3, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Aug 28, 2026 |
| CRVS | soquelitinib Angel Pharmaceuticals Phase 1b/2 trial in atopic dermatitis (cohort 1) | late 2026 “Results from cohort 1 (100 mg twice per day, 200 mg once per day and placebo) are anticipated late this year.” | PR · Aug 6, 2026 | Est. Nov 7, 2026 guidance midpoint | Reported ✓ Nov 4, 2026 |
| CRVS | soquelitinib soquelitinib Phase 2 trial in asthma (US) - initiation guided | Q4 2026 “Corvus also plans to initiate a Phase 2 clinical trial of soquelitinib in patients with asthma later this year.” | PR · Sep 30, 2026 | Est. Nov 15, 2026 quarter midpoint | Reported ✓ Nov 4, 2026 |
| FDMT | 4D-150 SPECTRA in DME | Q4 2026 “SPECTRA clinical trial 2-year data expected in Q4 2026” | PR · Aug 13, 2026 | Est. Nov 15, 2026 quarter midpoint | Reported ✓ Sep 28, 2026 |
| GILD | BIC/LEN ARTISTRY-1 & -2 in QD oral HIV treatment | 2H 2026 “BIC/LEN, ARTISTRY-1 & -2, QD Oral HIV Treatment, FDA Decision” | Deck · Aug 4, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Aug 27, 2026 |
| GLUE | MRT-8102 GFORCE-1 Phase 1 | H2 2026 “Readout of MRT-8102 GFORCE-1 study in subjects with elevated CVD risk anticipated in H2 2026.” | PR · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Oct 1, 2026 |
| GMAB | petosemtamab LiGeR-HN1 Phase 3 (frontline head and neck) · NCT06525220 | Q4 2026 “the full line study is expected to readout in the fourth quarter” | Call · Aug 6, 2026 | Est. Nov 15, 2026 quarter midpoint | Reported ✓ Oct 28, 2026 |
| HUMA | ATEV sBLA for dialysis access | H2 2026 “supplemental Biologic License Application (sBLA) for dialysis access to be filed with the Food and Drug Administration (FDA) during the second half of 2026” | PR · Aug 12, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Oct 23, 2026 |
| IDYA | IDE849 global Phase 1/2 first clinical data (SCLC/NEC) | H2 2026 “IDEAYA also plans to provide the first clinical data from its ongoing global Phase 1/2 trial of IDE849 in SCLC and NEC in the second half of 2026.” | PR · Aug 4, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Oct 23, 2026 |
| INKT | agenT-797 randomized Phase 2 C-1300-02 in severe acute lung injury | H2 2026 “Preliminary data expected in the second half of 2026” | PR · May 14, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Aug 13, 2026 |
| INSM | brensocatib regulatory decision for non-cystic fibrosis bronchiectasis in Japan | H2 2026 “Insmed continues to anticipate a regulatory decision for brensocatib for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in Japan in the second half of 2026.” | PR · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Aug 24, 2026 |
| IOVA | lifileucel (Amtagvi, UK) UK MAA for Amtagvi | later in 2026 “The MAA for Amtagvi in the UK was resubmitted in early July and is undergoing expedited review by the Medicines and Healthcare products Regulatory Agency (MHRA) for potential appro” | PR · Aug 6, 2026 | Est. Nov 7, 2026 guidance midpoint | Reported ✓ Oct 29, 2026 |
| IRON | bitopertin Phase 3 APOLLO in erythropoietic protoporphyria | Q4 2026 “The anticipated readout of the Phase 3 APOLLO trial of bitopertin in EPP in Q4 marks a significant milestone.” | PR · Jul 30, 2026 | Est. Nov 15, 2026 quarter midpoint | Reported ✓ Oct 19, 2026 |
| JNJ | teclistamab (TECVAYLI) + talquetamab (TALVEY) combination in relapsed refractory multiple myeloma | H2 2026 “We also have important data readouts across our Innovative Medicine pipeline, including TECVAYLI in combination with TALVEY for patients with relapsed refractory multiple myeloma w” | Call · Jul 15, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Oct 16, 2026 |
| KYMR | KT-579 KT-579 Phase 1 in healthy volunteers | Q4 2026 “Enrollment is ongoing in the KT-579 Phase 1 clinical trial in healthy volunteers, with data expected in the fourth quarter of 2026.” | PR · Aug 5, 2026 | Jan 12 - Feb 23 | Reported ✓ Oct 29, 2026 |
| MANE | VDPHL01 confirmatory Phase 3 Study 304 in male pattern hair loss | 2H 2026 “Topline data from Study '304', a confirmatory Phase 3 trial evaluating the safety and efficacy of VDPHL01 in the treatment of male pattern hair loss, are expected in the second hal” | PR · Aug 11, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Oct 19, 2026 |
| MIRM | LIVMARLI (maralixibat) Phase 3 EXPAND study in cholestatic pruritus due to additional rare cholestatic conditions | Q4 2026 “LIVMARLI EXPAND Phase 3 study in cholestatic pruritus due to additional rare cholestatic conditions topline results expected in Q4 2026.” | PR · Aug 5, 2026 | Est. Nov 15, 2026 quarter midpoint | Reported ✓ Oct 12, 2026 |
| MRNA | Intismeran autogene Phase 3 adjuvant melanoma study | H2 2026 (interim analysis) “So we're not going to disclose any more details around the specific timing, aside from that it's second half in terms of powering.” | Call · Jul 31, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Oct 22, 2026 |
| NKTR | rezpegaldesleukin REZOLVE-AA Phase 2b 24-week off-treatment data in alopecia areata | Q4 2026 “We expect to have data from the 24-week off-treatment period of the phase II-B REZOLVE-AA study in alopecia areata in the fourth quarter of this year.” | Call · Aug 13, 2026 | Est. Nov 15, 2026 quarter midpoint | Reported ✓ Oct 1, 2026 |
| ONCY | pelareorep REO 033 Part A initial tumor response update in RAS-mutant MSS colorectal cancer | year-end 2026 “It also expects to report an initial tumor response update from patients enrolled in Part A by year-end 2026 and, subject to FDA feedback, initiate enrollment in Part B of the stud” | PR · Jul 13, 2026 | — | Reported ✓ Nov 4, 2026 |
| PHAR | leniolisib Phase II in CVID patients with immune dysregulation | Q4 2026 “Pharming expects to report Phase II results for leniolisib in CVID patients with immune dysregulation, with or without an identified genetic cause, in the fourth quarter of 2026.” | PR · Sep 22, 2026 | Est. Nov 15, 2026 quarter midpoint | Reported ✓ Sep 22, 2026 |
| PVLA | QTORIN rapamycin rolling NDA for microcystic lymphatic malformations, completion of submission | H2 2026 “First module of the rolling NDA for QTORIN rapamycin for microcystic lymphatic malformations submitted to FDA, with completion of the NDA submission on track for the second half of” | PR · Aug 4, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Aug 31, 2026 |
| PYXS | MICVO + pembrolizumab Updated MICVO + pembrolizumab data in 1L R/M HNSCC | Q4 2026 “We expect to report updated monotherapy data in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (2L+ R/M HNSCC) this fall, followed by updated fir” | PR · Aug 13, 2026 | Est. Nov 15, 2026 quarter midpoint | Reported ✓ Sep 9, 2026 |
| RFL | Trappsol Cyclo TransportNPC pivotal Phase 3 main study cohort topline | 2H 2026 “Topline data from the main study cohort is expected to be known and announced in the second half of calendar 2026.” | PR · Jun 10, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Sep 30, 2026 |
| ROIV | IMVT-1402 Proof-of-concept trial in cutaneous lupus erythematosus (CLE) | 2H 2026 “Immunovant expects to report topline data from the proof-of-concept trial of IMVT-1402 in CLE and provide an update on the potentially registrational program of IMVT-1402 in D2T RA” | PR · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Sep 23, 2026 |
| ROIV | mosliciguat Phase 2 trial in PH-ILD | 2H 2026 “Pulmovant expects to report topline data from the ongoing Phase 2 trial of mosliciguat in PH-ILD in the second half of calendar year 2026.” | PR · Aug 6, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Sep 8, 2026 |
| SNDX | axatilimab (IPF) Phase 2 in idiopathic pulmonary fibrosis (IPF) | Q4 2026 “Topline data expected in 4Q26 from Phase 2 trials of axatilimab in IPF and frontline cGVHD” | PR · Aug 4, 2026 | Est. Nov 15, 2026 quarter midpoint | Reported ✓ Oct 12, 2026 |
| SPTX | SPT-300 (GlyphAllo, driving simulation) Phase 1 driving simulation trial | H2 2026 “Topline data from the driving simulation trial are expected in the second half of 2026” | PR · Aug 3, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Sep 9, 2026 |
| TRAX | ANB033 Phase 1b in celiac disease, Cohort 1 | Q4 2026 “We will report top-line data from Cohort 1 of the Phase 1b trial in Q4 2026, evaluating ANB033's potential to prevent gluten-induced mucosal injury.” | PR · Aug 12, 2026 | Est. Nov 15, 2026 quarter midpoint | Reported ✓ Oct 12, 2026 |
| VNDA | VQW-765 Phase 3 trial of VQW-765 in social anxiety disorder | Q4 2026 “Results for three Phase III clinical trials expected by end of 2026: NEREUS™ (tradipitant) in vomiting in GLP-1, VQW-765 in social anxiety disorder, HETLIOZ® (tasimelteon) in delay” | PR · Aug 5, 2026 | Est. Nov 15, 2026 quarter midpoint | Reported ✓ Oct 14, 2026 |
| VNDA | tasimelteon (HETLIOZ) Phase 3 trial of tasimelteon (HETLIOZ) in delayed sleep phase disorder | Q4 2026 “Results for three Phase III clinical trials expected by end of 2026: NEREUS™ (tradipitant) in vomiting in GLP-1, VQW-765 in social anxiety disorder, HETLIOZ® (tasimelteon) in delay” | PR · Aug 5, 2026 | Est. Nov 15, 2026 quarter midpoint | Reported ✓ Sep 29, 2026 |
| ZBIO | obexelimab EMA Marketing Authorization Application submission for obexelimab in IgG4-related disease | 2H 2026 “Zenas expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the second half of 2026.” | PR · Sep 8, 2026 | Est. Nov 7, 2026 half midpoint | Reported ✓ Oct 12, 2026 |